Combined orthodontic movement of teeth with temporomandibular joint therapy

ABSTRACT

Systems, devices and methods are disclosed for concurrently treating temporomandibular joint dysfunction (TMD) and orthodontically moving teeth. The devices can have an orthodontic aligner and a TMD treatment device. The devices can be configured to concurrently reposition a mandible and orthodontically move one or more teeth.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.62/397,765 filed Sep. 21, 2016, which is herein incorporated byreference in its entirety for all purposes.

BACKGROUND 1. Technical Field

Systems, devices and methods for treating temporomandibular jointdysfunction (TMD) are disclosed. More specifically, systems, devices andmethods are disclosed for treating TMD concurrently with dental and/ororthodontic treatment.

2. Background of the Art

Temporomandibular dysfunction affects a large portion of the populationand is regarded as multifactorial condition with a multitude ofetiologies and treatment modalities. Some estimates suggest that over 10million Americans are affected by temporomandibular dysfunction.

The temporomandibular joint (TMJ) is a complex joint that connects thejaw to the temporal bones of the skull. These joints allow movement ofthe jaw to go up and down and side to side, which facilitates talking,chewing, yawning and the like. Problems with this joint and the musclesof mastication are known as temporomandibular joint disorders (TMDs),although problems with this joint and the associated muscles aresometimes referred to as TMJ disorders as well. TMD occurs where themandibular condyle does not sit or move properly in the glenoid fossa ofthe petrous portion of the temporal bone.

There are many different causes of TMD, for example, trauma, whiplash,arthritis, dislocation of the cartilage disc in the joint, stress,clenching or grinding of the teeth, or malocclusions. Dentistry andorthodontics can also cause symptoms of TMD to manifest.

TMD symptoms can range from slight to debilitating, including, forexample, wearing of the teeth, clicking, popping, or grating of the TMJ(e.g., when opening or closing the mouth), internal derangement of thejoint (e.g., displaced disc, dislocated jaw, or injury to the mandibularcondyle), headaches, myofascial pain, radiating pain in the face, jaw,or neck, stiffness in the jaw, limited movement or locking of the jaw,arthritis, and malocclusions.

There are many different schools of thought with respect to treatmentmodalities for TMD within the medical and dental profession. As many ofthese treatment modalities involve various appliances that cover theteeth and take the pressure off the joint and muscles, the ultimate goalis to treat TMD patients with a TMD appliance to the point where theyare no longer dependent on appliance therapy.

Current TMD treatment modalities include various TMD appliances thatadjust the position of the jaw, for example, mandibular advancementappliances (e.g., Herbst appliances, elastic mandibular advancement(EMA) appliances), stabilization splints (e.g., nightguards, dayguards), and deprogrammers. Current modalities also includeorthodontically moving the teeth. However, no treatment modalitycurrently exists that simultaneously moves teeth and provides TMDtreatment that is separate and apart from the orthodontic movement ofteeth (e.g., via braces or a retainer). A need therefore exists toaddress this deficiency, as TMD appliances, when used separately fromorthodontic treatments that move teeth, can cause teeth to shift andcompel subsequent orthodontic treatment to correct the resultingmalocclusions, and orthodontic treatments that move teeth, when usedseparately from TMD appliances, can cause TMD even though theorthodontic movement of teeth can treat TMD. Further, since TMDappliances cause teeth to move, current TMD appliances becomenonfunctional as soon as the teeth move, for example, into new positionsthat can in turn cause new TMD issues. The new TMD issues either requirethe teeth to be orthodontically moved, and/or the use of a second (e.g.,new) TMD appliance to accommodate the shifted teeth. Accordingly, a needcurrently exists to combine the two modalities, i.e., to combine theorthodontic movement of teeth with TMD appliance therapy.

The present disclosure addresses this need by combining orthodontic andTMD treatments, including malocclusion correction and/or bitemaintenance (e.g., preventative treatment that inhibits one or moreteeth from moving into a malocclusion position, and/or that encouragesone or more teeth to move into a new position that will accommodate theresultant TMD therapy position). Simultaneously (as opposed toincidentally and/or sequentially) orthodontically moving teeth andproviding TMD appliance therapy can advantageously ease or eliminatesymptoms associated with TMD, shorten the length of TMD treatment, andreduce the cost of TMD treatment, all while attaining a desirabletherapeutic result that reduces or eliminates the need to seesaw backand forth between TMD appliance therapy and the orthodontic movement ofteeth to sequentially correct the problems that each treatment modalitycauses when used separately.

The present disclosure simultaneously considers TMJ position andocclusion while treating both, with the end result being a patient witha pain free smile. By combining orthodontic and TMD treatments, thecombined therapy results in ideal dental, muscular and joint position atthe completion of treatment, as opposed to only dental position or onlyjoint position as is the case with the current modalities that are usedseparately.

Comprehensive dental treatments should include consideration of thestructures involved, including the TMJ, muscles of mastication, teethand gums. The present disclosure allows the dental provider to combineTMD therapy and orthodontic treatment to end with a result that thepatient considers a beautiful smile with harmonious joint and muscles.For example, the present disclosure allows for numerous different TMDtreatment modalities to be treated with orthodontic alignerssimultaneously. The TMD treatment modalities can include mandibularadvancement style appliances and/or palatal and mandibular expandersusing the orthodontic aligners. By manipulating the 3D models thealigners can act both as orthodontic movers of teeth along with idealpositioning of the TMJ and muscle.

A need exists to combine orthodontic and/or dental treatment with TMDappliances. The advantages of combining these modalities include: (1)moving and/or maintaining the teeth into a position that accommodatesthe new TMD treatment position of the lower jaw, (2) existing TMDdevices and appliances can cause malocclusions to develop which bydesign can be prevented or otherwise mitigated with the oral appliancesdisclosed herein, (3) the oral appliances disclosed herein can betitrated over a series of two or more steps for ideal mandibularadvancement and/or opening and for the ideal orthodontic movement ofteeth with software, and/or (4) the oral appliances disclosed herein canallow free mandibular motion while having the ability to hold the jointin a fixed position if necessary for the desired treatment or comfort ofthe patient.

BRIEF SUMMARY OF THE INVENTION

This disclosure relates generally to the combined orthodontic movementand/or dental treatment of teeth and TMD treatment.

More specifically, orthodontic and/or dental TMD treatment systems,apparatuses and methods of using the same are disclosed. The TMDtreatment systems and apparatuses disclosed can concurrently move teethand treat TMD. The TMD treatment systems and apparatuses disclosed canconcurrently advance the mandible and move teeth. The TMD treatmentsystems and apparatuses disclosed can concurrently expand the hardand/or soft palate and move teeth. The TMD treatment systems andapparatuses disclosed can concurrently whiten and/or move teeth andtreat TMD. The TMD treatment systems and apparatuses disclosed canconcurrently clean and/or move teeth and treat TMD. The TMD treatmentsystems apparatuses disclosed can concurrently move teeth, advance themandible, expand the hard and/or soft palate, whiten teeth, applyhygienic treatment, treat TMD, or any combination thereof.

The TMD treatment systems and apparatuses can have dental trays and/ororthodontic aligner trays. The TMD treatment systems apparatuses canhave craniofacial adjustment blocks. The craniofacial adjustment blockscan be attached to or integrated with one or more trays (e.g.,aligners).

Oral appliances are disclosed for the combined orthodontic movement ofteeth and treatment of temporomandibular joint dysfunction (TMD). Forexample, an oral appliance is disclosed that can have an orthodonticaligner and a TMD treatment device. The oral appliance can be configuredto concurrently reposition a mandible and orthodontically move one ormore teeth.

Systems for the combined orthodontic movement of teeth and treatment oftemporomandibular joint dysfunction (TMD) are disclosed. For example, asystem is disclosed that can have a series of oral appliances. Theseries of oral appliances can be configured to concurrently repositionboth a mandible and orthodontically move one or more teeth. Each oralappliance in the series can have an orthodontic tray and a TMD treatmentdevice.

Methods of progressively treating temporomandibular joint dysfunction(TMD) are disclosed. For example, a method is disclosed that can includeproviding a series of oral appliances. The series of oral appliances canbe configured to concurrently reposition both a mandible andorthodontically move one or more teeth. Each oral appliance in theseries can have an orthodontic tray and a TMD treatment device.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings shown and described are exemplary embodiments andnon-limiting. Like reference numerals indicate identical or functionallyequivalent features throughout.

FIG. 1 illustrates isometric views of a variation of craniofacialadjustment blocks of an oral appliance.

FIG. 2 illustrates a top elevational view of the oral appliance of FIG.1.

FIG. 3 illustrates a side isometric view of the oral appliance of FIG. 1in a fully engaged and assembled configuration under compression.

FIGS. 4a, 4b, and 4c illustrate a schematic of a variation of lockingmechanisms of an oral appliance.

FIG. 5 illustrates a schematic of a variation of an aligner on teeth.

FIG. 6 illustrates a schematic of a variation of a maxillary aligner onteeth that has a variation of a craniofacial adjustment block.

FIG. 7 illustrates a schematic of a variation of maxillary andmandibular aligners on teeth with each having a variation of acraniofacial adjustment block.

FIG. 8 illustrates a schematic of a variation of a series of oralappliances.

FIG. 9 illustrates a variation of a process for making a variation of anoral appliance.

DETAILED DESCRIPTION

Systems, devices and methods are disclosed that can concurrently applyTMD treatment, apply orthodontic treatment, apply dental treatment, orany combination thereof. The systems, devices and methods disclosed canapply orthodontic treatment to any craniofacial structure, including thedentition, the palate, the maxilla, the mandible, or any combinationthereof. The systems, devices and methods disclosed can apply any dentaltreatment to the teeth, including whitening treatments, cleaningtreatments, gingival recession treatments, or any combination thereof.For example, systems, devices and methods are disclosed that canconcurrently move one or more teeth, advance the mandible, retrude themandible, expand the hard and/or soft palate, whiten teeth, clean teeth,treat gum line recession, reshape the airway, maintain the airway, orany combination thereof.

The disclosed systems, devices and methods can treat TMD by manipulatingone or more craniofacial structures. TMD can be treated by repositioningthe jaw and/or by adjusting the bite, for example, by widening thedental arches, by increasing the interocclusal distance between theupper and lower teeth and/or by advancing the lower jaw. The position ofthe jaw can be adjusted concurrently with the orthodontic treatment of,for example, misaligned teeth, malocclusions, and/or narrow arches.Additionally or alternatively, the position of the jaw can be adjustedconcurrently with a teeth whitening, cleaning and/or gingival recessiontreatment.

More particularly, oral appliances are disclosed that can reposition thejaw and/or adjust the bite to treat TMD. The oral appliances disclosedcan also reshape and/or maintain the airway to treat sleep breathingdisorders (SBD) such as obstructive sleep apnea (OSA) and snoring. Theoral appliances disclosed can reposition the jaw, adjust the bite,and/or reshape the airway by simultaneously manipulating one or morecraniofacial structures and moving teeth, cleaning teeth, whiteningteeth, or any combination thereof. The oral appliances disclosed cantreat TMD, SBD, and snoring with various orthodontic treatmentmodalities, for example, mandibular advancement and/or palatalexpansion. The oral appliances disclosed can simultaneously provide bothorthodontic and TMD treatment and result in more properly aligned teethand a reduction or elimination in TMD symptoms. The oral appliancesdisclosed can simultaneously provide orthodontic, TMD, and SBD treatmentand result in more properly aligned teeth, a reduction or elimination inTMD symptoms, and/or a more open airway. The oral appliances disclosedcan simultaneously provide dental whitening, dental cleaning and/orgingival recession treatments in combination with TMD and/or SBDtreatment and result in whiter teeth, cleaner teeth, healthier gums,fresher breath, a reduction or elimination in TMD symptoms, and/or amore open airway.

System and Apparatus

TMD appliance therapy can be combined with the orthodontic movement ofteeth, for example, with orthodontic aligner treatment. For example, TMDappliances such as mandibular advancement appliances (e.g., Herbstappliances, elastic mandibular advancement (EMA) appliances),stabilization splints (e.g., nightguards, day guards), deprogrammers(e.g., anterior deprogrammers), flat planes, and full contact splintswith anterior guidance can be used and combined with, attached to,removably attached to, integrated with, or have oral tray aligners thatcan orthodontically move teeth concurrently with TMD treatment. The TMDappliances can provide TMJ positioning that allows both the jaw to moveand that holds the jaw in position during treatment, for example, withina movement range such that movement of the jaw is permitted butconstrained, or such that movement of the jaw is not permitted andcompletely constrained.

The TMD appliances disclosed can simultaneously reposition the jaw andorthodontically move teeth, for example, by virtue of their combinationwith aligner treatment. The systems disclosed however, not only simplyallow for their combination, the systems also advantageously allow fortheir treatments to be coordinated with one another. For example, themovement of one or more teeth that the TMD aligners disclosed (e.g., thecombination of a TMD device and an orthodontic aligner) can cause isseparate from the movement of teeth that TMD appliances otherwise solelycause without the use of concurrent aligner treatment. For example,whereas the aligner treatment that this disclosure combines with TMDappliances causes one or more teeth to move into a desired or a moredesirable position, current TMD appliances without the combined alignertreatment cause teeth to move into an undesired or a less desirableposition. The orthodontic/TMD appliances disclosed avoid such undesiredconcomitant movement associated with solo TMD appliance use byorthodontically moving the teeth into a position that is physiologicallycorrect for the TMJ and musculature during TMD treatment with a TMDappliance. Custom TMD appliances can be attached to or integrated withorthodontic tray aligners as well. TMD appliances and orthodontic trayaligners can be monolithically formed, or can be assembled from one ormore parts.

The orthodontic movement of teeth can include malocclusion correction(e.g., moving one or more teeth into a new position, including into afinal position and/or into one or more intermediate positions prior tothe final position) and/or bite maintenance (e.g., preventativetreatment that inhibits one or more teeth from moving into amalocclusion position, and/or that encourages one or more teeth to moveinto a new position that will accommodate the resultant TMD therapyposition, or that will accommodate the final TMJ position that isdesired). Simultaneously (as opposed to sequentially) orthodonticallymoving teeth and providing TMD appliance therapy can advantageously easeor eliminate symptoms associated with TMD, shorten the length of TMDtreatment, and reduce the cost of TMD treatment, all while attaining adesirable therapeutic result that reduces or eliminates the need toseesaw back and forth between TMD appliance therapy and the orthodonticmovement of teeth to sequentially correct the problems that eachtreatment modality causes when used separately.

For example, FIG. 1 illustrates a variation of a customizable oralappliance 10 for treating TMD. The oral appliance 10 can be astabilization splint that can stabilize the mandible in one or morepositions. For example, the oral appliance 10 can be a stabilizationsplint that can advance the mandible, for example, by stabilizing themandible in a forward position. The appliance 10 can have one or moremaxillary blocks 12 and one or more mandibular blocks 14. The maxillaryand mandibular blocks 12, 14 are also referred to as guides,craniofacial adjustment blocks, and TMD components (both individuallyand collectively) throughout. For example, the appliance 10 can have 1to 6 maxillary blocks 12 and 1 to 6 mandibular blocks 14. The number ofmaxillary blocks 12 can be less than, equal to, or greater than thenumber of mandibular blocks 14. For example, FIG. 1 illustrates that theappliance 10 can have two maxillary blocks 12 and two mandibular blocks14. As another example, the appliance 10 can have one maxillary block 12and two mandibular blocks 14 or vice versa. The appliance 10 can haveone, two, three, four, or five more maxillary blocks 12 than mandibularblocks 14 or vice versa. The appliance 10 can have one or more maxillaryblocks 12 and no mandibular blocks 14 or one or more mandibular blocks14 and no maxillary blocks 12. The blocks 12, 14 can be placed in aperson's oral cavity.

FIG. 1 illustrates that the appliance 10 can have a first maxillaryblock 12 a and a second maxillary block 12 b. Anatomically, themaxillary first block 12 a can be a left block and the maxillary secondblock 12 b can be a right block, or vice versa. The maxillary first andsecond blocks 12 a, 12 b can be configured to be placed on a lateralleft and right side, respectively, of a maxillary dental arch. Theappliance 10 can have a first mandibular block 14 a and a secondmandibular block 14 b. Anatomically, the mandibular first block 14 a canbe a left block and the mandibular second block 14 b can be a rightblock, or vice versa. The mandibular first and second blocks 14 a, 14 bcan be configured to be placed on a lateral left and right side,respectively, of a mandibular dental arch.

FIG. 1 illustrates that the blocks 12, 14 can each have a buccal side16, a lingual side 18, an anterior portion 20, a posterior portion 22and teeth surfaces 24. Each maxillary block 12 can have a maxillarytooth surface 24 a and/or a mandibular tooth surface 24 b. Eachmandibular block 14 can have a maxillary tooth surface 24 a and/or amandibular tooth surface 24 b. The surfaces 24 can conform to surfacesof the teeth and/or can have a geometry to orthodontically move one ormore teeth from one position to another. One or more of the surfaces 24of maxillary and mandibular blocks can be configured to have a frictionfit over a portion of one or more teeth.

The maxillary tooth surfaces 24 a of the maxillary blocks 12 can have asurface geometry configured to move one or more maxillary teeth from afirst position to a second position. The mandibular tooth surfaces 24 bof the maxillary blocks 12 can be flat (e.g., as shown in FIG. 1) or canhave a surface geometry configured to move one or more mandibular teethfrom a first position to a second position. The mandibular toothsurfaces 24 b of the mandibular blocks 14 can have a surface geometryconfigured to move one or more mandibular teeth from a first position toa second position. The maxillary tooth surfaces 24 a of the mandibularblocks 14 can be flat (e.g., as shown in FIG. 1) or can have a surfacegeometry configured to move one or more maxillary teeth from a firstposition to a second position.

A series of blocks 12, 14 can be designed to progressively repositionthe maxillary and/or mandibular teeth in two or more successive steps,for example, as disclosed in PCT Publication WO 2016/004415 and U.S.application Ser. No. 15/386,280 (published as US 2017/0100214) inrelation to orthodontic trays, both of which are herein incorporated byreference in their entireties for all purposes. Each block 12, 14 in aseries can have a surface 24 that has a geometry that corresponds to anintermediate or end tooth arrangement intended for the block 12, 14 inthe series. The blocks 12, 14 can be sufficiently resilient toaccommodate or conform to misaligned teeth, but apply sufficient forceagainst the misaligned teeth to reposition the teeth to the intermediateor end arrangement as desired for the particular treatment step. Aseries of blocks 12, 14 can have geometries selected to progressivelyreposition teeth from a first arrangement through one or more successiveintermediate arrangements to a final arrangement. Each block in theseries can have the same or different dimensions than one or more otherblocks in the series, as described below. A series of blocks 12, 14 canhave 1 to 100 maxillary blocks 12 and 1 to 100 mandibular blocks 14, forexample, 1 to 55 maxillary blocks 12 and 1 to 55 mandibular blocks 14, 1to 50 maxillary blocks 12 and 1 to 50 mandibular blocks 14, 1 to 45maxillary blocks 12 and 1 to 45 mandibular blocks 14, 1 to 40 maxillaryblocks 12 and 1 to 40 mandibular blocks 14, less than 40 maxillaryblocks 12 and less than 40 mandibular blocks, or any combinationthereof. For example, a series of blocks can have 40, 41, 42, 43, 44,45, 46, 47, 48, 49, or 50 maxillary blocks 12 and 40, 41, 42, 43, 44,45, 46, 47, 48, 49, or 50 mandibular blocks 14. The number of maxillaryblocks 12 can be the same or different as the number mandibular blocks14 in a series.

FIG. 1 illustrates that the maxillary blocks 12 can each have one ormore maxillary block guide surfaces 26 (e.g., 1 to 6 or more maxillaryguide surfaces 26) and that the mandibular blocks 14 can each have oneor more mandibular block guide surfaces 28 (e.g., 1 to 6 or moremandibular guide surfaces 28). The guide surfaces 26, 28 are variouslyreferred to throughout as ramps, stops, disclusion surfaces, expansionsurfaces, resting surfaces and/or other similar terms. The guidesurfaces 26 can be on any part or define any surface of the blocks 12,14, for example, the anterior and/or posterior portions 20, 22 of themaxillary and mandibular blocks 12, 14.

FIG. 1 illustrates that the anterior portion 20 of the maxillary blocks12 can have one maxillary guide surface 26 and that the posteriorportion 22 of the mandibular blocks 14 can have one mandibular guidesurface 28. For example, FIG. 1 illustrates that the maxillary first andsecond blocks 12 a, 12 b can have maxillary first and second guidesurfaces 26 a, 26 b, respectively, and that the mandibular first andsecond blocks 14 a, 14 b can have mandibular first and second guidesurfaces 28 a, 28 b, respectively. The exact number and orientation ofthe guide surfaces 26, 28 can be customizable and depend on a person'stolerance for the blocks 12, 14, craniofacial structure, teethalignment, orthodontic treatments being applied, TMD treatment beingapplied, dental treatment being applied or any combination thereof, eachfactor being critical to the design of the blocks 12, 14. Each block ina series can have the same or different number and/or orientation ofguide surfaces 28 a, 28 b as one or more other blocks in the series.

While FIG. 1 illustrates that the anterior portions 20 of the maxillaryblocks 12 and the posterior portions 22 of the mandibular blocks 14 havethe guide surfaces 26, 28 (e.g., guide surfaces 26 a, 26 b, 28 a, 28 b),the anterior and/or posterior portion 20, 22 of each of the maxillaryand mandibular blocks can have one or more guide surfaces in addition toor in lieu of the guide surfaces 26, 28 shown in FIG. 1. For example,the posterior portions 22 of the maxillary blocks 12 can have guidesurfaces and/or the anterior portions 20 of the mandibular blocks 14 canhave guide surfaces. However, the anterior and/or posterior portions 20,22 of the maxillary and/or mandibular blocks 12 need not have a guidesurface. For example, FIG. 1 illustrates that the posterior portions 22of the maxillary blocks 12 and the anterior portions 20 of themandibular blocks 14 can have ends that do not have a guide surface.FIG. 1 illustrates that the ends of the posterior portions 22 of themaxillary blocks 12 and the anterior portions 20 of the mandibularblocks 14 can have a flat or curved surface with a portion that isperpendicular or nearly perpendicular to an occlusal plane.

Each guide surface (e.g., guide surfaces 26, 28) can be paired with anopposing (also referred to as cooperating, interacting, engaging,contacting, or interfering) guide surface. For example, the blocks 12,14 can be paired such that their corresponding guide surfaces 26, 28form one or more corresponding guide surfaces pairs 26-28. Each guidesurface in a guide surface pair can be configured to interact with itsopposing guide surface. For example, the opposing guide surfaces of aguide surface pair 26-28 can be configured to slidably engage orotherwise move relative to one another and/or be configured to restagainst each other or otherwise inhibit or prevent movement relative toone another. At least a portion of each guide surface, including theentire guide surface, can be configured to contact at least a portion ofits opposing guide surface, including the entire opposing guide surface,such that any portion 100% or less is appreciated. FIG. 1 illustratesthat the two left blocks 12 a, 14 a can form a left guide surface pair26 a-28 a and that the two right blocks 12 b, 14 b can form a rightguide surface pair 26 b-28 b. The maxillary and mandibular guidesurfaces 26 a, 28 a of the left pair 26 a-28 a can be designed tointeract with each other and the maxillary and mandibular guide surfaces26 b, 28 b of the right pair 26 b-28 b can be designed to interact witheach other. Each guide surface 26, 28 can interact with its opposingguide surface in a self-guided manner. The guide surfaces 26, 28 canposition the mandible in a joint position that treats TMD (e.g., a jointposition that relieves or eliminates TMD symptoms) while the teeth aremoving or otherwise encouraged to move orthodontically.

Each guide surface 26, 28 can be or have one or more planar surfaces(e.g., 1 to 50 planar surfaces). For example, FIG. 1 illustrates thateach guide surface 26, 28 can have one planar surface. However, theguide surfaces 26, 28 can have any surface geometry, including planar,curved (e.g., one or more concave and/or convex portions), polygonal(e.g., any combination of two or more planes), irregular, or anycombination thereof. Thus, although the guide surfaces 26, 28 canfunction as guide planes and may be planar in general characteristics,strict conformity with flatness associated with a plane is not required.

The guide surfaces 26, 28 can be angled such that they define one ormore inclined, horizontal, and/or declined planar surfaces. The guidesurfaces 26, 28 can be at one or more angles relative to, for example, areference plane, reference surface, or reference axis. FIG. 1illustrates that the maxillary guide surfaces 26 (e.g., the maxillaryfirst and second guide surfaces 26 a, 26 b) can each be at maxillaryguide surface angle 30. The maxillary guide surface angle 30 can be theangle formed between the maxillary guide surfaces 26 and a referenceplane, reference surface, or reference axis such as the maxillary toothsurface 24 a (or an occlusal plane), maxillary orthodontic aligner (notshown), or any combination thereof. The maxillary guide surface angle 30can be from about 0 degrees to about 90 degrees or more broadly fromabout 0 degrees to about 150 degrees. For angles greater than 90degrees, the maxillary guide surface 26 can face toward as opposed toaway from the maxillary dentition. For example, the maxillary guidesurface angle 30 can be from about 15 degrees to about 75 degrees, fromabout 40 degrees to about 50 degrees, from about 30 degrees to about 60degrees, from about 20 degrees to about 70 degrees, or from about 10degrees to about 80 degrees, including every 1 degree increment withinthese ranges; for example, the maxillary guide surface angle 30 can beabout 0 degrees, about 5 degrees, about 10 degrees, about 15 degrees,about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees,about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees,about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees,about 80 degrees, about 85 degrees, about 90 degrees, about 130 degrees,about 135 degrees, about 140 degrees, about 145 degrees, or about 150degrees. Angles within these ranges and/or having these values canadvantageously allow the maxillary and mandibular blocks 12, 14 toslidably engage or otherwise move relative to one another and/or restagainst each other or otherwise inhibit or prevent movement relative toone another. Angles within these ranges and/or having these values canadvantageously allow the maxillary and mandibular blocks 12, 14 tocontact (e.g., slidably contact) each other to move and/or maintain themandible into a forward position and/or to increase and/or maintain theinterocclusal separation between the maxillary and mandibular dentalarches. Angles within these ranges and/or having these values cantherefore advantageously facilitate treating TMD by repositioning thejaw and/or by adjusting the bite. Angles within these ranges and/orhaving these values can also facilitate the reshaping of the airway intoa more open configuration (e.g., from a less open first configuration toa more open second configuration). Each maxillary block 12 in a seriescan have the same or different maxillary guide surface angle 30 as oneor more other maxillary blocks 12 in the series.

FIG. 1 illustrates that the mandibular guide surfaces 28 (e.g., themandibular first and second guide surfaces 28 a, 28 b) can each be at amandibular guide surface angle 32. The mandibular guide surface angle 32can be the angle formed between the mandibular guide surfaces 28 and areference plane, reference surface, or reference axis such as themandibular tooth surface 24 b (or an occlusal plane), mandibularorthodontic aligner (not shown), or any combination thereof. Themandibular guide surface angle 32 can be from about 0 degrees to about90 degrees or more broadly from about 0 degrees to about 150 degrees.For angles greater than 90 degrees, the mandibular guide surface 28 canface toward as opposed to away from the mandibular dentition. Forexample, the mandibular guide surface angle 32 can be from about 15degrees to about 75 degrees, from about 40 degrees to about 50 degrees,from about 30 degrees to about 60 degrees, from about 20 degrees toabout 70 degrees, or from about 10 degrees to about 80 degrees,including every 1 degree increment within these ranges; for example, themandibular guide surface angle 32 can be about 0 degrees, about 5degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85degrees, about 90 degrees, about 130 degrees, about 135 degrees, about140 degrees, about 145 degrees, or about 150 degrees. Angles withinthese ranges and/or having these values can advantageously allow themaxillary and mandibular blocks 12, 14 to slidably engage or otherwisemove relative to one another and/or rest against each other or otherwiseinhibit or prevent movement relative to one another. Angles within theseranges and/or having these values can advantageously allow the maxillaryand mandibular blocks 12, 14 to contact (e.g., slidably contact) eachother to move and/or maintain the mandible into a forward positionand/or to increase and/or maintain the interocclusal separation betweenthe maxillary and mandibular dental arches. Angles within these rangesand/or having these values can therefore advantageously facilitatetreating TMD by repositioning the jaw and/or by adjusting the bite.Angles within these ranges and/or having these values can alsofacilitate the reshaping of the airway into a more open configuration(e.g., from a less open first configuration to a more open secondconfiguration). Each mandibular block 14 in a series can have the sameor different maxillary guide surface angle 32 as one or more othermandibular blocks in the series.

FIG. 1 illustrates that the maxillary and mandibular guide surfaceangles 30, 32 of a maxillary and mandibular block pair (e.g., pair 12a-14 a, pair 12 b-14 b) can be any two complementary or nearlycomplementary angles. For example, the first and second block pairs 12a-14 a and 12 b-14 b can have angle pairs (listed as angle-angle, indegrees) of about 45-45, 40-50, 35-55, 30-60, 25-65, 20-70, 15-75,10-80, 5-85, or vice versa—about 45-45, 50-40, 55-35, 60-30, 65-25,70-20, 75-15, 80-10, 85-5. The maxillary blocks 12 can have the firstlisted complementary angle and the mandibular blocks 14 can have thesecond listed complementary angle in each of the angle-angle pairs. Themandibular blocks 14 can have the first listed complementary angle andthe maxillary blocks 12 can have the second listed complementary anglein each of the angle-angle pairs. In this way, the maxillary andmandibular blocks 12, 14 can form cooperating pairs of blocks 12-14 andguide surfaces 26-28 as described above. However, the maxillary andmandibular guide surface angles 30, 32 can be non-complementary andstill enable one or more portions of each of the guide surfaces 26, 28to cooperate with one another. Moreover, the guide surfaces 26, 28 neednot form surface angles 30, 32—which can occur where, for example, theguide surfaces are irregular, curved, polygonal, or any combinationthereof, yet still advantageously be configured to interact and functionas guide surfaces.

FIG. 1 illustrates that the maxillary first and second blocks 12 a, 12 bcan have maxillary first and second guide surface angles 30 a, 30 b,respectively. The maxillary first and second guide surface angles 30 a,30 b can be the same or different from one another. For example, themaxillary first guide surface angle 30 a can be less than, equal to, orgreater than the maxillary second guide surface angle 30 b. Themaxillary first guide surface angle 30 a can be from about 1 degree toabout 90 degrees greater or less than the maxillary second guide surfaceangle 30 b, more narrowly from about 1 degree to about 45 degreesgreater or less than the maxillary second guide surface angle 30 b, morenarrowly yet from about 1 degree to about 30 degrees greater or lessthan the maxillary second guide surface angle 30 b, still more narrowlyfrom about 1 degree to about 15 degrees greater or less than themaxillary second guide surface angle 30 b, yet still more narrowly fromabout 1 degree to about 5 degrees greater or less than the maxillarysecond guide surface angle 30 b, or vice versa.

FIG. 1 illustrates that the mandibular first and second blocks 14 a, 14b can have mandibular first and second guide surface angles 32 a, 32 b,respectively. The mandibular first and second guide surface angles 32 a,32 b can be the same or different from one another. For example, themandibular first guide surface angle 32 a can be less than, equal to, orgreater than the mandibular second guide surface angle 32 b. Themandibular first guide surface angle 32 a can be from about 1 degree toabout 90 degrees greater or less than the mandibular second guidesurface angle 32 b, more narrowly from about 1 degree to about 45degrees greater or less than the mandibular second guide surface angle32 b, more narrowly yet from about 1 degree to about 30 degrees greateror less than the mandibular second guide surface angle 30 b, still morenarrowly from about 1 degree to about 15 degrees greater or less thanthe mandibular second guide surface angle 32 b, yet still more narrowlyfrom about 1 degree to about 5 degrees greater or less than themandibular second guide surface angle 32 b, or vice versa.

FIG. 1 illustrates that the maxillary guide surfaces 26 can extend awayfrom an occlusal surface of the maxillary dentition and/or from amaxillary oral tray (not shown, e.g., a maxillary orthodontic tray), forexample, toward the mandible. The mandibular guide surfaces 28 canextend away from an occlusal surface of the mandibular dentition and/ora mandibular oral tray (not shown, e.g., a mandibular orthodontic tray),for example, toward the maxilla. Each guide surface (e.g., guidesurfaces 26, 28) can have a first end and a second end. The first andsecond ends can be the base of the guide surface and the second end canbe the top of the guide surface. The base of the maxillary guide surface26 can be closer to a surface of a maxillary tooth and/or maxillary oraltray than the top of the maxillary guide surface 26 and the base of themandibular guide surface 28 can be closer to a surface of a mandibulartooth and/or mandibular oral tray than the top of the mandibular guidesurface 28. For example, FIG. 1 illustrates that the bases of themaxillary and mandibular guide surfaces 26, 28 can be proximate to andextend from maxillary and mandibular occlusal surfaces, respectively,toward the opposing dentition; however, one or more of the bases can beoffset from the occlusal surface or oral tray such that the offsetbase(s) are separated from the dentition or a surface of a maxillary ormandibular oral tray by about 0.5 mm to about 50 mm. The tops can beproximate to or separated from (e.g., by about 0.5 mm to about 50 mm)the opposing dentition. FIG. 1 illustrates that the tops of themandibular guide surfaces 28 can be configured to be proximate themaxillary detention and/or oral tray and that the tops of the maxillaryguide surfaces 26 can be configured to be separated from the mandibulardentition and/or oral tray.

The guide surfaces 26, 28 can extend along any portion of a length of ablock, for example, 100% or less, 75% or less, 50% or less, 25% or less.For example, FIG. 1 illustrates that each guide surface 26, 28 canextend about 33% along a length of its respective block, therebyadvantageously providing a large guide surface. Guide surfaces 26, 28that extend along greater than about 10% of a length of a block canadvantageously enable each block 12, 14 in a treatment series to be usedfor greater treatment period before a user graduates to the next block.Guide surfaces greater than this 10% threshold can reduce the number ofblocks 12, 14 required in a treatment series. Guide surfaces greaterthan this 10% threshold can increase user comfort and tolerance for usererror. Although not illustrated, each maxillary ramp 26 can extend about100% along the length of a maxillary block 12, for example, from amaxillary block first end to a maxillary block second end such that themaxillary blocks 12 have a shape of a triangular wedge when viewed fromthe side. Similarly, each mandibular ramp 28 can extend about 100% alongthe length of a mandibular block 14, for example, from a mandibularblock first end to a mandibular block second end such that themandibular blocks 14 have a shape of a triangular wedge when viewed fromthe side.

FIG. 1 illustrates that the maxillary and mandibular guide surfaces 26,28 can be sloped longitudinally such that the angles 30, 32 are theangles that are formed as the guide surfaces 26, 28 extendlongitudinally across the blocks 12, 14, for example, from the anteriorportion 20 to the posterior portion 22 of the blocks 12, 14. As aresult, the guide surfaces 26, 28 can form one or more longitudinalslopes. Additionally or alternatively, the maxillary and mandibularguide surfaces 26, 28 can be sloped transversely such that the angles30, 32 can be the angles that are formed as the maxillary guide surfaces26 extend laterally across the block, for example, from a first lateralside to a second lateral side (e.g., left to right and/or right to left)of the blocks 12, 14, or from a longitudinal center to a first and/orsecond lateral side of the blocks 12, 14. As a result, the guidesurfaces 26, 28 can form one or more transverse slopes. Each guidesurface 26, 28 can have a longitudinal and/or transverse slope. Thelongitudinal and transverse guide surfaces can have the same ordifferent slope from one another. For example, one or more guidesurfaces can have a longitudinal slope of about 35 degrees and atransverse slope of about 20 degrees. The one or more longitudinalslopes can reposition the jaw and/or adjust the bite by advancing themandible. The one or more transverse slopes can reshape the airway bycausing palatal expansion, for example, by exerting an outward force onthe dentition. Each block in a series can have the same or differentlongitudinal and/or transverse slope(s) as one or more other blocks inthe series.

FIG. 1 illustrates the relative positions of the maxillary andmandibular blocks 12, 14 relative to the maxillary and mandibular dentalarches, respectively. The maxillary blocks 12 (e.g., maxillary first andsecond blocks 12 a, 12 b) can be configured to overlay one or moreposterior teeth and/or one or more anterior teeth. The maxillary blocks12 can be configured to overlay a central incisor, a lateral incisor, acanine, one or more premolars, one or more molars, or any combinationthereof. FIG. 1 illustrates that the maxillary first and second blocks12 a, 12 b can overlay a portion of the posterior ends of the maxillarydental arch, for example, the second and third molars. The mandibularblocks 14 (e.g., mandibular first and second blocks 14 a, 14 b) can beconfigured to overlay one or more posterior teeth and/or one or moreanterior teeth. The mandibular blocks 14 (e.g., mandibular first andsecond blocks 14 a, 14 b) can be configured to overlay a centralincisor, a lateral incisor, a canine, one or more premolars, one or moremolars, or any combination thereof. FIG. 1 illustrates that themandibular first and second blocks 14 a, 14 b can overlay the posteriorends and an anterior portion of the mandibular dental arch, for example,the second premolar and the first, second and third molars. Each blockin a series can have the same or different relative position as one ormore other blocks in the series.

The location of the maxillary and/or mandibular blocks 12, 14 relativeto a dentition and/or to each other can be determined by a dentist,orthodontist, one or more computer algorithms, or a combination thereof.For example, a computer program can be used to retrieve data from oraldata acquisition devices (e.g., scanners, x-ray devices, cameras) torecord and measure orthodontic malocclusions and teeth misalignments. Acomputer program can be used to retrieve data from oral data acquisitiondevices to record and measure the orthodontic correction ofmalocclusions and misalignments during treatment.

FIGS. 2 and 3 illustrate that the maxillary blocks 12 (e.g., maxillaryfirst and second blocks 12 a, 12 b) can each have a length 12 _(L), awidth 12 _(w) and a height 12 _(H). The length 12 _(L) can be from about1 mm to about 50 mm, including every 0.5 mm increment between about 1 mmand about 50 mm, for example, about 15.0 mm. The width 12 _(w) can befrom about 1 mm to about 30 mm, including every 0.5 mm increment betweenabout 1 mm and about 30 mm, for example, 8.0 mm. The height 12 _(H) canbe from about 1 mm to about 50 mm, including every 0.5 mm incrementbetween about 1 mm and about 50 mm, for example, 10.0 mm. Each maxillaryblock 12 in a series can have the same or different length 12 _(L),width 12 _(w), and/or height 12 _(H) as one or more other maxillaryblocks 12 in the series. The lengths 12 _(L) of multiple or successivemaxillary blocks 12 can each have the same length or one or moredifferent lengths 12 _(L). For example, the lengths 12 _(L) of multipleor successive maxillary blocks 12 can become progressively longer,progressively shorter, follow another progressive pattern (e.g.,increase and/or decrease), or remain constant. For example, the lengths12 _(L) of the maxillary blocks 12 in a series can increase from about15.0 mm to about 20.0 mm, vice versa (e.g., decrease from about 15.0 mmto about 10.0 mm), increase from about 15.0 to about 18.0 mm and thendecrease to about 16.5 mm, or remain constant at about 15.0 mm. Thewidths 12 _(w) of multiple or successive maxillary blocks 12 can eachhave the same width or one or more different widths 12 _(w). Forexample, the widths 12 _(w) of multiple or successive maxillary blocks12 can become progressively longer, progressively shorter, followanother progressive pattern (e.g., increase and/or decrease), or remainconstant. For example, the widths 12 _(w) of the maxillary blocks 12 ina series can increase from about 8.0 mm to about 13.0 mm, vice versa(e.g., decrease from about 8.0 mm to about 3.0 mm), increase from about8.0 to about 11.0 mm and then decrease to about 10.0 mm, or remainconstant at about 8.0 mm. The heights 12 _(H) of multiple or successivemaxillary blocks 12 can each have the same height or one or moredifferent heights 12 _(H). The height 12 _(H) can be a maximum height.For example, the heights 12 _(H) of multiple or successive maxillaryblocks 12 can become progressively longer, progressively shorter, followanother progressive pattern (e.g., increase and/or decrease), or remainconstant. For example, the heights 12 _(H) of the maxillary blocks 12 ina series can increase from about 10.0 mm to about 15.0 mm, vice versa(e.g., decrease from about 15.0 mm to about 10.0 mm), increase fromabout 8.0 to about 11.0 mm and then decrease to about 10.0 mm, or remainconstant at about 10.0 mm.

FIGS. 2 and 3 illustrate that the mandibular blocks 14 (e.g., mandibularfirst and second blocks 14 a, 14 b) can each have a length 14 _(L), awidth 14 _(w) and a height 14 _(H). The length 14 _(L) can be from about1 mm to about 50 mm, including every 0.5 mm increment between about 1 mmand about 50 mm, for example, about 35.0 mm. The width 14 _(w) can befrom about 1 mm to about 30 mm, including every 0.5 mm increment betweenabout 1 mm and about 30 mm, for example, 8.0 mm. The height 12 _(H) canbe from about 1 mm to about 50 mm, including every 0.5 mm incrementbetween about 1 mm and about 50 mm, for example, 3.0 mm. Each mandibularblock 14 in a series can have the same or different length 14 _(L),width 14 _(w), and/or height 14 _(H) as one or more other mandibularblocks 14 in the series. The lengths 14 _(L) of multiple or successivemandibular blocks 14 can each have the same length or one or moredifferent lengths 14 _(L). For example, the lengths 14 _(L) of multipleor successive mandibular blocks 14 can become progressively longer,progressively shorter, follow another progressive pattern (e.g.,increase and/or decrease), or remain constant. For example, the lengths14 _(L) of the mandibular blocks 14 in a series can increase from about35.0 mm to about 40.0 mm, vice versa (e.g., decrease from about 35.0 mmto about 30.0 mm), increase from about 35.0 to about 38.0 mm and thendecrease to about 36.5 mm, or remain constant at about 35.0 mm. Thewidths 14 _(w) of multiple or successive mandibular blocks 14 can eachhave the same width or one or more different widths 14 _(w). Forexample, the widths 14 _(w) of multiple or successive mandibular blocks14 can become progressively longer, progressively shorter, followanother progressive pattern (e.g., increase and/or decrease), or remainconstant. For example, the widths 14 _(w) of the mandibular blocks 14 ina series can increase from about 8.0 mm to about 13.0 mm, vice versa(e.g., decrease from about 8.0 mm to about 3.0 mm), increase from about8.0 mm to about 11.0 mm and then decrease to about 10.0 mm, or remainconstant at about 8.0 mm. The heights 14 _(H) of multiple or successivemandibular blocks 14 can each have the same height or one or moredifferent heights 14 _(H). The height 14 _(H) can be a maximum height.For example, the heights 14 _(H) of multiple or successive mandibularblocks 14 can become progressively longer, progressively shorter, followanother progressive pattern (e.g., increase and/or decrease), or remainconstant. For example, the heights 14 _(H) of the mandibular blocks 14in a series can increase from about 3.0 mm to about 8.0 mm, vice versa(e.g., decrease from about 3.0 mm to about 0.5 mm), increase from about3.0 mm to about 6.0 mm and then decrease to about 4.5.0 mm, or remainconstant at about 3.0 mm.

The length 12 _(L) can be greater than, equal to, or less than thelength 14 _(L). For example, FIG. 2 illustrates that the length 12 _(L)can be less than the length 14 _(L). The width 12 _(w) can be greaterthan, equal to, or less than the width 14 _(w). For example, FIG. 2illustrates that the width 12 _(w) can be about equal to the width 14_(w). The height 12 _(H) can be greater than, equal to, or less than theheight 14 _(H). For example, FIG. 2 illustrates that the height 12 _(H)can be less than the height 14 _(H). Each block 12, 14 can have one ormore lengths, widths, heights, or any combination thereof.

FIG. 3 illustrates that the guide surfaces 26 (e.g., guide surface 26 b)can have a guide surface length 26 _(L) and that the guide surfaces 28(e.g., guide surface 28 b) can have a guide surface length 28 _(L). Thesurface length 26 _(L) can be from about 1 mm to about 50 mm, includingevery 0.5 mm increment between about 1 mm and about 50 mm, for example,about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm,about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm. The surfacelength 28 _(L) can be from about 1 mm to about 50 mm, including every0.5 mm increment between about 1 mm and about 50 mm, for example, about5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm,about 17 mm, about 18 mm, about 19 mm, about 20 mm. Each block in aseries can have the same or different guide surface length 26 _(L) asone or more other blocks in the series. The guide surface lengths 26_(L) of multiple or successive maxillary blocks 12 can each have thesame length or one or more different lengths 26 _(L). For example, theguide surface lengths 26 _(L) of multiple or successive maxillary blocks12 can become progressively longer, progressively shorter, followanother progressive pattern (e.g., increase and/or decrease), or remainconstant. For example, the guide surface lengths 26 _(L) of themaxillary blocks 12 in a series can increase from about 10.0 mm to about20.0 mm, vice versa (e.g., decrease from about 10.0 mm to about 5.0 mm),increase from about 10.0 to about 13.0 mm and then decrease to about 5.0mm, or remain constant at about 10.0 mm. The guide surface lengths 28_(L) of multiple or successive mandibular blocks 14 can each have thesame length or one or more different lengths 28 _(L). For example, theguide surface lengths 28 _(L) of multiple or successive mandibularblocks 12 can become progressively longer, progressively shorter, followanother progressive pattern (e.g., increase and/or decrease), or remainconstant. For example, the guide surface lengths 26 _(L) of themandibular blocks 12 in a series can increase from about 10.0 mm toabout 20.0 mm, vice versa (e.g., decrease from about 10.0 mm to about5.0 mm), increase from about 10.0 to about 13.0 mm and then decrease toabout 5.0 mm, or remain constant at about 10.0 mm.

FIG. 3 illustrates that one or more of the maxillary and mandibularblocks 12, 14 can have a free surface 25 (also referred to as a hangingsurface) positioned opposite a tooth surface 24 (e.g., tooth surface 24a and/or 24 b) that is configured to not contact an opposing block(e.g., any surface of the opposing block), an opposing dental ororthodontic tray, an opposing dentition, or any combination thereof. Forexample, FIG. 1 illustrates that one or more maxillary blocks 12 canhave a free surface 25. The maxillary first block 12 a can have amaxillary first block hanging surface 25 a and/or the maxillary secondblock 12 b can have a maxillary second block hanging surface 25 b. Ahanging surface 25 can advantageously provide more space for the tonguein the oral cavity, increase the size of the airway and help keep openthe airway. Additionally or alternatively, a hanging surface canadvantageously inhibit or prevent the blocks 12, 14 from triggering aperson's gag reflex, for example, by reducing the size of the oralappliance 10 positioned in the back of the oral cavity.

FIG. 3 illustrates that a gap can form between a free hanging surface 25(e.g., the maxillary second block hanging surface 25 b) and an opposingdentition (e.g., the mandibular dentition). The gap can be from about 0mm to about 50 mm, more narrowly from about 1 mm to about 20 mm, yetmore narrowly from about 1 mm to about 15 mm, yet still more narrowlyfrom about 1 mm to about 10 mm, including every 0.5 mm increment withinthese ranges, for example, about 5 mm, about 6 mm, about 7 mm, about 8mm, about 9 mm, about 10 mm. The gap can be the shortest distancebetween the free surface 25 and the opposing dental tray, orthodontictray, or teeth. The gap can be the greatest distance between the freesurface 25 and the opposing dental tray, orthodontic tray, or teeth. Thegap can be measured between any point on an opposing dental tray,orthodontic tray, or teeth to any point on the hanging surface 25. Thepoint on the hanging surface may or may not correspond with a point thatis closest to or farthest from the opposing dental tray, orthodontictray, or teeth.

FIG. 3 illustrates a variation of the relative positions of themaxillary and mandibular blocks 12, 14 to one another when the jaw is ina closed position. FIG. 3 illustrates that when the jaw is fully closedat least a portion of a posterior portion 22 of the maxillary blocks 12(e.g., the maxillary first and second blocks 12 a, 12 b) can beposterior to at least a portion of a posterior portion 22 of themandibular blocks 14 (e.g., the mandibular first and second blocks 14 a,14 b), or vice versa (if, for example, the positions of the blocks 12,14 are reversed such that the maxillary blocks 12 are placed in theirsame relative positions on the mandibular dental arch and the mandibularblocks 14 are place in their same relative positions on the maxillarydental arch). For example, FIG. 3 illustrates that the maxillary blocks12 do not extend anterior to the top of the ramp of the mandibularblocks 14, and are accordingly posterior to the remaining portion of themandibular blocks 14.

The dimensions and relative positions of the blocks 12, 14 disclosedherein will depend on, and can be customized to accommodate, forexample, a person's airway, dental and/or orthodontic needs, theiranatomy, the number of blocks in a series, the number oral trays in aseries, or any combination thereof; thus, although various positions,ranges and values are disclosed, each permutation of the disclosedpositions, ranges and values and equivalents thereof is consideredcritical to the overall design of the oral appliance 10, as eachcombination of dimensions and positions, when used together toreposition the jaw, adjust the bite, and/or reshape and/or maintain aperson's airway, is critical to providing the treatment desired.Additionally, each block in a series can have any combination of thedimensions and positions disclosed, as the design of each block in aseries will depend on a person's unique dentition and other craniofacialstructures as well as the implemented orthodontic, TMD, and/or SBDtreatment plan. If the foregoing disclosure yet lacks clarity, everypermutation of block dimensions and positions within the ranges andvalues disclosed is hereby explicitly disclosed, for example, in 0.1 mmincrements, such that any combination of block dimensions and/orrelative positions is claimable.

The first and second maxillary blocks 12 a, 12 b can be connected viaone or more maxillary connectors. The maxillary connector(s) can be awire, resilient wire, polymer strand, resilient polymer strand, dentaltray, orthodontic tray, or any combination thereof that conform to,extend along, or wrap around a buccal side, a lingual side, and/or anocclusal surface of at least a portion of the maxillary dental arch. Afirst end of the maxillary connector(s) can be attached to or integratedwith any portion of the maxillary first or second block 12 a, 12 b and asecond end of the maxillary connector(s) can be attached to orintegrated with any portion of the other of the maxillary first orsecond block 12 a, 12 b. The maxillary connector(s) can be used tostabilize the first and second maxillary blocks 12 a, 12 b. Themaxillary connector(s) can be designed and/or manipulated (e.g.,progressively manipulated over a series of treatments) toorthodontically move maxillary teeth. The first and second mandibularblocks 14 a, 14 b can be connected via one or more mandibularconnectors. The mandibular connector(s) can be a wire, resilient wire,polymer strand, resilient polymer strand, dental tray, orthodontic tray,or any combination thereof that conform to, extend along, or wrap arounda buccal side, a lingual side and/or an occlusal surface of at least aportion of the mandibular dental arch. A first end of the mandibularconnector(s) can be attached to or integrated with any portion of themandibular first or second block 14 a, 14 b and a second end of themandibular connector(s) can be attached to or integrated with anyportion of the other of the mandibular first or second block 14 a, 14 b.The mandibular connector(s) can be used to stabilize the first andsecond mandibular blocks 14 a, 14 b. The mandibular connector(s) can bedesigned and/or manipulated (e.g., progressively manipulated over aseries of treatments) to orthodontically move mandibular teeth.Orthodontic and dental trays are individually and collectively referredto throughout as oral trays such that an oral tray can be an orthodonticand/or a dental tray, for example, an aligner (also referred to as anorthodontic tray), a whitening tray, or an orthodontic teeth whiteningaligner that is configured to move and whiten at least one tooth. Oraltrays are also referred to as aligners and aligner componentsthroughout.

The blocks 12, 14 can be attached to or integrated with a maxillaryand/or mandibular oral tray. For example, the maxillary blocks 12 can beintegrated with a maxillary and/or mandibular oral tray and/or themandibular blocks 14 can be integrated with a maxillary and/ormandibular oral tray. A series of oral trays can be designed toprogressively reposition the maxillary and/or mandibular teeth in two ormore successive steps, for example, as disclosed in PCT Publication WO2016/004415 and U.S. application Ser. No. 15/386,280 (published as US2017/0100214), both of which have been incorporated herein by referencein their entireties for all purposes. Each oral tray in a series canhave a tooth surface that has a geometry that corresponds to anintermediate or end tooth arrangement intended for the oral tray in theseries. The oral trays can be sufficiently resilient to accommodate orconform to misaligned teeth, but apply sufficient force against themisaligned teeth to reposition the teeth to the intermediate or endarrangement as desired for the particular treatment step. A series oforal trays can have geometries selected to progressively repositionteeth from a first arrangement through one or more successiveintermediate arrangements to a final arrangement. A series of trays canhave 1 to 100 maxillary trays and 1 to 100 mandibular trays, forexample, 1 to 55 maxillary trays and 1 to 55 mandibular trays, 1 to 50maxillary trays and 1 to 50 mandibular trays, 1 to 45 maxillary traysand 1 to 45 mandibular trays, 1 to 40 maxillary trays and 1 to 40mandibular trays, less than 40 maxillary trays 12 and less than 40mandibular trays, including every 1 tray increment within these ranges,or any combination thereof. For example, a series of trays can have 40,41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 maxillary trays and 40, 41,42, 43, 44, 45, 46, 47, 48, 49, or 50 mandibular trays. The number ofmaxillary trays can be the same or different as the number mandibulartrays in a series. The trays can orthodontically move the teeth into oneor more correct physiological position. For example, the trays canorthodontically move the teeth into one or more positions that arephysiologically correct for the TMJ and musculature at the same time asTMD treatment with a TMD appliance.

Each tray in a series can be configured to move one or more teeth, orone or more trays in a series can be configured to not move any teeth.For example, where the mandibular teeth are in a desired alignment butthe position of the maxillary teeth are still in need of an adjustment,the mandibular tray can be configured to maintain the position of themandibular teeth and the maxillary tray can be configured to move one ormore maxillary teeth. Further, one or multiple dimensions of the TMDaspect of the oral appliance 10, for example the TMD craniofacialadjustment blocks 12 and 14 shown in FIGS. 1-3, can be progressivelyadjusted in a series of oral appliances 10 to progressively repositionthe jaw to alleviate and eliminate TMD, or alleviate or eliminate one ormore symptoms thereof. Each TMD component in a series can have anarrangement or geometry that corresponds to an intermediate or end jawposition intended for the TMD component in the series. The TMDcomponents can be sufficiently resilient to reposition the mandible tothe intermediate or end arrangement as desired for the particulartreatment step. A series of TMD components can have geometries selectedto progressively reposition the mandible from a first position throughone or more successive intermediate positions to a final position. Inthis way, the aligner component and/or the TMD component of the oralappliance 10 can concurrently and progressively orthodontically moveteeth and treat TMD, for example, by progressively adjusting the jawposition with each oral appliance 10 in a series. The number of oralappliances 10 in a series can be the same as that described herein withrespect to the number of oral trays in a series (e.g., as describedearlier in this paragraph).

The number of steps in a series for the aligner components to move oneor more teeth from an initial arrangement to a final arrangement can bethe same or different than the number of steps in a series for the TMDcomponents to move the jaw from an initial position to a final position.As a result, some aligner components (e.g., 1 to N_(A)−1 alignercomponents, where N_(A) is the total number of aligner components in aseries) may not have a geometry configured to move one or more teeth,instead having a geometry to maintain the position of one or more teethwhile the corresponding TMD component in the series can be configuredprogressively move the jaw to a new position (e.g., an intermediate or afinal position). Also, some TMD components (e.g., 1 to N_(T)−1 TMDcomponents, where N_(T) is the total number of TMD components in aseries) may not have an arrangement or geometry configured to move thejaw, instead having an arrangement or geometry to maintain the positionof the jaw while the corresponding aligner component in the series has ageometry configured to progressively move one or more teeth. The totalnumber of aligner and TMD components N_(A), N_(T) can be the same ordifferent from each, for example, N_(A) and N_(T) can each be the sameas the number of oral appliances 10 in a series, and N_(A) can begreater than, equal to, or less than N_(T) as described above. In thisway, the number of steps in a series for both the aligner and TMDcomponents can be the same number as the number of oral appliances 10 inthe series, or a lesser number, or can be the same number as the numberof aligner and TMD components in a series, respectively, or a lessernumber. As a result, the number of treatment steps for both the alignerand TMD components can be the same or fewer than the number ofcomponents in a series of appliances 10.

The blocks 12, 14 can be modular such that they can be removablyattached to a maxillary and/or mandibular oral tray, for example, to anorthodontic tray and/or to a dental tray (i.e., any tray without anorthodontic function). The blocks 12, 14 can be attached to one ormultiple oral trays with one or multiple attachment mechanisms (alsoreferred to as anchors), such as clasps, clips, hooks, elastic hooks,barbs, spurs, fasteners, or any combination thereof. Additionally oralternatively, the blocks 12, 14 can fit over a portion of an oral traywith a friction fit and/or a snap fit. For example, the oral tray canhave a ridge over which the blocks 12, 14 can be snapped. The ridge canextend at least partially along a surface of the oral tray. A first end(e.g., a base) of each maxillary block 12 can be anchored to a maxillaryoral tray. A second end (e.g., a top portion) of each maxillary block 12can be anchored to a mandibular oral tray. A first end (e.g., a base) ofeach mandibular block 14 can be anchored to a mandibular oral tray. Asecond end (e.g., a top portion) of each mandibular block 14 can beanchored to a maxillary oral tray. A modular block design can beespecially advantageous where a series of orthodontic trays are designedas disclosed in WO 2016/004415, as the modular design can allow thereuse and/or repositioning of the blocks 12, 14 along the arch of themaxillary and/or mandibular dentition on a single aligner or on multiplesuccessive aligners. The modular design can advantageously allow therepositioning of one or more blocks 12, 14 from a first position on anoral tray to one or more other positions on the oral tray different fromthe first position. For example, the modular design can allow therepositioning each block (e.g., blocks 12 and/or 14) in a series 1 to100 times on one or multiple oral trays, including every increment of 1between 1 and 100. A modular design can also advantageously allow aseries of blocks to be mixed and matched with each oral tray in an oraltray series.

One or both guide surfaces of a guide surfaces pair 26-28 (e.g., pair 26a-28 a and/or pair 26 b-28 b) can have a coating or otherwise comprise amaterial which permits relative motion between two opposed guidesurfaces in a first direction and resists relative motion between twoopposed guide surfaces in a second direction opposite the firstdirection. For example, the mandibular blocks 14 can be configured toengage the maxillary blocks 12 and slide forward along the guidesurfaces 26 of the maxillary blocks 12 upon the application of acompressive force between two opposing maxillary and mandibular blocks12, 14 (e.g., upon closing the jaw from an open position or by otherwise“biting down” on the blocks 12, 14). As another example, the mandibularblocks 14 can be configured to engage the maxillary blocks 12 and slideforward along the guide surfaces 26 of the maxillary blocks 12 in afirst direction when the jaw relaxes or is voluntarily opened and thenrelaxed and be prevented or inhibited from sliding along the guidesurfaces 26 in a second direction opposite the first direction. Theguide surfaces (e.g., guide surfaces 26 and/or 28) can have a firstcoefficient of friction associated with movement of the mandibularblocks 12 in a first direction and a second coefficient of frictionassociated with movement of the mandibular blocks 12 in a seconddirection opposite the first direction. The second coefficient offriction can be greater than the first coefficient of friction. Thefirst and second coefficients of friction can be static coefficients offriction μ_(s). The first and second coefficients of friction can bekinetic coefficients of friction μ_(k).

One or both guide surfaces of a guide surface pair 26-28 (e.g., pair 26a-28 a and/or pair 26 b-28 b) can have a coating or otherwise comprise amaterial (e.g., an adhesive or a ferromagnetic material) which inhibitsrelative motion between two opposed guide surfaces when they interact.Additionally or alternatively, one or more magnets can be placed in theblocks 12, 13 such that the maxillary blocks 12 magnetically attract themandibular blocks 14 and vice versa.

The maxillary and mandibular blocks 12, 14 can comprise a thermoplasticmaterial. The maxillary and mandibular blocks 12, 14 can be thermoformedwith the aid of a computer algorithm. The maxillary and mandibularaligners can comprise a thermoplastic material. The maxillary andmandibular aligners can be thermoformed with the aid of a computerprogram. The maxillary blocks 12 and the maxillary aligners can beattached to, integrated with, or monolithically formed with one another.The mandibular blocks 14 and the mandibular aligners can be attached to,integrated with, or monolithically formed with one another.

The maxillary and mandibular blocks 12, 14 can be rigid such that theyresist deformation under pressure or semi-rigid such that they permitdeformation and/or are compliant under pressure. Semi-rigid and/orcompliant materials can advantageously increase user comfort andprevent, inhibit, or limit TMD, for example, sleep bruxism.

The blocks 12, 14 can be solid or hollow. For example, the blocks 12, 14can have one or more airway channels (e.g., 1 to 10 or more airwaychannels). The airway channels can extend at least partially laterallyand/or at least partially longitudinally through the blocks 12, 14. Theairway channels can extend through the blocks 12, 14 from the buccalside 16 to the lingual side 18. The airway channels can extend throughthe blocks 12, 14 from an anterior side to a posterior side. One or moreof the airway channels of a maxillary block 12 can be at least partiallyaligned (e.g., partially or completely collinear) with one or morechannels of a mandibular block 14. Each channel can have an anterior endand a posterior end. A posterior end of the channel of an anterior block(e.g., the mandibular blocks 14 in FIG. 1) can overlap completely orpartially with an anterior end of the channel of a posterior block(e.g., the maxillary blocks 12 in FIG. 1). The posterior ends of theairway channels of the posterior blocks (e.g., the maxillary blocks 12in FIG. 1) can be directed toward the pharynx to facilitate inhalationand exhalation. A posterior portion of the airway channels in theposterior blocks (e.g., the maxillary blocks 12 in FIG. 1) can be curvedsuch that the posterior ends of the posterior blocks are directed towardthe pharynx or the base of the tongue. The airway channels can bestraight, curved, tapered, or any combination thereof.

A cooperating pair of blocks 12-14 can have 1 to 10 or more airwaychannels. For example, the cooperating pair of blocks 12 a-14 a and 12b-14 b can each have one maxillary airway channel and two mandibularairway channels extending at least partially longitudinally and/orlaterally through the blocks 12 a, 12 b, 14 a, 14 b. One of themandibular airway channels can be at least partially aligned with themaxillary airway channel. The three airway channels (the one maxillaryand two mandibular channels) can thereby advantageously form two airwaychannels from an anterior portion of the oral appliance 10 to aposterior portion of the oral appliance 10. The one or more airwaychannels in the oral appliance 10 can decrease the amount of dead spacein the oral cavity by increasing the size of the oral cavity availablefor airflow through the oral cavity by allowing air to flow through theblocks 12, 14. By increasing the volume in the oral cavity available forairflow, the one or more airway channels can advantageously reduce theamount of respiratory effort required for inhalation and exhalationand/or decrease the velocity of the air passing through oral cavity, andcan therefore, in turn, prevent, inhibit, and/or reduce the likelihoodof an SBD event and/or the occurrence of snoring while using the TMDappliance 10. The one or more airway channels can and/or can helpprevent, inhibit, and/or reduce SBD and/or snoring.

The airway channels can be substantially the same size as the block orany lesser size, collectively or individually. For example, a transverseand/or longitudinal cross-sectional area of the airway channels can beabout 1% to about 100% of a transverse and/or longitudinalcross-sectional area of the blocks 12, 14, more narrowly from about 1%to about 95%, more narrowly still from about 1% to about 90%, includingevery 1% increment within these ranges, for example, about 25%, 50%,75%, 90%, or 95%. A length of the airway channels can be about 1% toabout 100% of a length of the blocks 12, 14, more narrowly from about 1%to about 90%, more narrowly still from about 1% to about 80%, includingevery 1% increment within these ranges, for example, about 25%, 50%,75%, or 95%. The airway channels can extend laterally across the blocks12, 14 such that the airway channels extend across about 1% to about100% the width of a block, more narrowly from about 1% to about 90%,more narrowly still from about 1% to about 80%, including every 1%increment within these ranges, for example, about 25%, 50%, 75%, or 95%.

One or more sensors can be positioned in one or multiple airwaychannels, integrated into a wall of one or multiple airway channels,integrated or positioned on an outer surface of one or multiple blocks12, 14, integrated in one or multiple blocks 12, 14, integrated orpositioned on one or more oral trays, or any combination thereof. Theone or more sensors can be flow sensors, pressure sensors, temperaturesensors, or any combination thereof. The sensor(s) can be incommunication with a controller configured to activate an alarm when anobstruction is detected, for example, when a flow sensor detects astoppage or reduction in flow that exceeds a time interval threshold,when a pressure sensor detects a drop in pressure that exceeds apressure drop threshold, when a temperature sensor detects a temperatureincrease of exhaled or oral cavity air that exceeds a temperaturethreshold, or any combination thereof. The alarm can be auditory and/ortactile (e.g., vibration), and can be emitted from an alarm mechanism,including, for example, the controller. The controller can be integratedwith the TMD device 10 or be in wireless communication therewith. Thecontroller can be configured to communicate an alarm signal to asmartphone or other computing device which can process the signal andemit an auditory and/or tactile alarm. The alarm can be configured towake a person up from a potentially dangerous SBD event. One or moresensors (e.g., one or more pressure sensors) can be in communicationwith the controller to detect whether the oral appliance 10 is properlyor improperly positioned. The controller can be configured to activatean alarm if the oral appliance 10 is improperly positioned, for example,if it becomes dislodged when a person is sleeping (e.g., if one or morepressure sensors detect a pressure drop that exceeds a pressure dropthreshold).

FIGS. 4a, 4b, and 4c illustrate that the appliance 10 can haveattachable or interlockable maxillary and mandibular aligners, which canfriction-fit, screw-fit, snap-fit, or otherwise couple to each other andlock the appliance 10 in a treatment position. TMD treatment can lockthe jaw into position, for example, into an intermediate or finalposition in each of the corresponding steps of a treatment series. Forexample, FIGS. 4a, 4b, and 4c illustrate that the appliance 10 can haveone or more locking mechanisms 42 that can lock the jaw into position(e.g., into a TMD treatment position, for example, one or more desiredintermediate positions, or the final desired position). For example, theappliance 10 can have one or more maxillary locking mechanisms 42 aand/or one or more mandibular locking mechanisms 42 b. For example, theappliance 10 can have 1 to 5 maxillary locking mechanisms 42 a and/or 1to 5 mandibular locking mechanisms 42 b. The number of maxillary lockingmechanisms 42 a can be less than, equal to, or greater than the numberof mandibular locking mechanisms 42 b. For example, FIGS. 4a, 4b, and 4cillustrate that the appliance 10 can have three maxillary lockingmechanisms 42 a and three mandibular locking mechanisms 42 b.

The maxillary and mandibular aligners 38 a, 38 b, each of which can haveone or more TMD devices or components attached or integrated therewith,can be attached to (e.g., interlockable with) one another, for example,via the one or more locking mechanisms 42. The locking mechanisms 42 caninterlock with one another such that the maxillary aligner 38 a can beattached to the mandibular aligner 38 b. The locking mechanisms 42 caninterlock with an aligner 38 and/or to the TMD aspect of the appliance10. The locking mechanisms 42 can be attached to the aligners 38 (e.g.,maxillary aligner 38 a and/or mandibular aligner 38 b) and/or to one ormore TMD devices or components of the appliance 10.

The locking mechanisms 42 can have an unlocked configuration and one ormore locked configurations (e.g., 1, 2, 3, 4, or 5 or more lockedconfigurations). For example, the locking mechanisms 42 can have first,second, third, fourth, and/or fifth locked configurations that can besequentially lockable (e.g., with the first configuration lockable firstand the fifth configuration lockable last). Each locked configurationcan permit or restrict a different amount of movement relative toanother locked configuration, including a complete constraint onmovement relative to the locked configuration. Each locked configurationcan permit or restrict the same amount of movement relative to the otherlocked configurations, including a complete constraint on movementrelative to the locked configuration. Each locked configuration can lockthe maxillary and mandibular together a different distance apart. Forexample, the first, second, third, fourth, and fifth lockedconfigurations can lock the maxillary and mandibular aligners (e.g.,aligners 38 a and 38 b) from about 1 mm to about 5 mm, from about 6 mmto about 10 mm, from about 11 mm to about 15 mm, from about 16 mm toabout 20 mm, and from about 21 mm to about 25 mm, respectively, or viceversa. The multiple locked configurations can each correspond to adifferent treatment step for a TMD component such that the number oflockable configurations corresponds to a number of sub-treatment stepsfor each TMD component in each step of a series of oral appliances 10.

When in a locked configuration, the locking mechanisms 42 can preventthe jaw from moving (e.g., opening or closing vertically or moving fromside to side) and/or can limit the amount by which the lower jaw is ableto move, for example, by preventing or limiting the amount of relativemovement between the aligners 38 and/or between one or more aspects ofthe TMD devices or components of the appliance 10. For example, when thelocking mechanisms 42 are engaged and the appliance 10 is in a lockedconfiguration, the locking mechanisms 42 can prevent all movement of thelower jaw (e.g., by preventing all relative movement between thealigners 38). As another example, when the locking mechanisms 42 areengaged and the appliance 10 is in a locked configuration, the lockingmechanisms 42 can allow the lower jaw to have one, two, three, four,five, or six degrees of freedom such that the lower jaw is translatablealong and/or rotatable about one, two, and/or three axes (e.g., alongand/or about one, two, and/or three mutually perpendicular axes such asx, y, and/or z Cartesian axes). To permit the lower jaw to move, thelocking mechanisms 42 can permit relative movement between the aligners38 and/or between one or more aspects of the TMD devices or componentsof the appliance 10. For example, when in a locked configuration, thelocking mechanisms 42 can permit the lower jaw to translate from about0.5 mm to about 5 mm, including every 0.5 mm increment within thisrange, for example, about 2.0 mm, along one, two, or three axes. Forexample, when in a locked configuration, the locking mechanisms canpermit the lower jaw to rotate from about 1 degree to about 30 degrees,including every 1 degree increment within this range, for example, about10 degrees, about one, two, or three axes. When in a lockedconfiguration, the locking mechanisms 42 can be in a neutral, or “zero,”position, and translation and/or rotation of the jaw can be measuredrelative to this neutral position. For example, movement of themandibular aligner 38 b can be measured relative to the TMD aspect ofthe appliance 10 and/or relative to the maxillary aligner 38 a such thatthe translational and angular ranges described above refer to thedisplacements of the mandibular aligner 38 b that are permitted when thelocking mechanisms 42 are in a locked configuration and the lower jawmoves.

The locking mechanisms 42 can impart a restorative force to the lowerjaw to return to the neutral position once displaced (e.g., translatedand/or rotated) away from the neutral position. Additionally oralternatively, the locking mechanisms 42 can include one or more elasticbands and/or guide surfaces apart from the locking mechanisms 42 toimpart a restorative force or otherwise encourage a return to theneutral position.

The locking mechanisms 42 can be tethers clasps, clips, hooks, elastichooks, barbs, spurs, fasteners, elastic bands, interlocking male andfemale components, or any combination thereof. The elastic bands canwrap around one or more hooks attached to or integrated with theappliance 10. For example, FIGS. 4a, 4b, and 4c illustrates that themaxillary locking mechanisms 42 a can each be a male component that canfit into or otherwise lock with a corresponding mandibular lockingmechanism 42 b, where each mandibular locking mechanism 42 b can have afemale receptor configured to receive the male maxillary lockingmechanisms 42 a.

The male and female locking mechanisms 42 a and 42 b can position/lockthe lower jaw in a desired position (e.g., an improved or correctposition) while the teeth are moving orthodontically, or while anorthodontic force is being exerted on the teeth to move themorthodontically. The male locking mechanisms 42 a can have a protrusion(e.g., a ridge) that fits into a groove or slot of the female lockingmechanisms 42 a. The locking mechanisms can be on the maxillary andmandibular guide surfaces 26, 28.

The male component can be a protrusion and the female component can be arecess, a groove, or a hole. The male component can have a form factorthat is slightly larger than the female component to generate aninterference fit. For example, the protrusion can have a form factorthat is slightly larger than the recess, hole, or groove such that aninterference fit is produced when the protrusion is inserted into therecess, hole, or groove. The male component can have a form factor thatis slightly smaller than the female component to generate aninterference fit. For example, the protrusion can have a form factorthat is slightly smaller than the recess, hole, or groove such that aninterference fit is produced when the protrusion is inserted into therecess, hole, or groove. A maxillary block 12 a can be attached to amandibular block 12 b and/or to a mandibular aligner 38 b via thelocking mechanism 42 (e.g., 42 a and/or 42 b). A maxillary aligner 38 acan be attached to a mandibular block 12 b and/or to a mandibularaligner 38 b via the locking mechanisms (e.g., 42 a and/or 42 b).

Different blocks 12 and/or aligners 38 in a series can have differentdegrees of freedom when in an attached configuration. Changing themotion permitted by the jaw during treatment with different appliances10 in the series can desirably prevent or inhibit the user fromdeveloping new TMD symptoms and/or allow the TMD device 10 to treat TMD.The appliances 10 in the series can restrict movement of the lower jawdifferently than one or more preceding appliances 10 and/or differentlythan one or more subsequent appliances 10. The amount of movement or thedegrees of freedom can be changed for every appliance 10 in the series,or every 2-50 appliances 10 in the series, including every 1 applianceincrement within this range, for example, every 5 appliances 10.

Method of Use

The TMD appliance 10, or a series of TMD appliances 10, can be placed inan oral cavity as shown in FIG. 3.

The blocks 12, 14 can force the mandible forward, for example, due theinteraction between the blocks 12, 14 when a person bites down on theblocks after the oral appliance is placed in the oral cavity.

The size and/or shape of the blocks 12, 14 can be configured toencourage a person to move their mandible forward with or without bitingdown on the blocks 12, 14. For example, the blocks 12, 14 can interactto move the mandible forward when a person bites down on the blocks 12,14. However, a person can use the blocks 12, 14 with or without movingtheir mandible forward. The size and/or shape of the blocks 12, 14 canbe configured to advance a person's mandible. The size and/or shape ofthe blocks 12, 14 can be configured to not advance a person's mandible.

The size and/or shape of the blocks 12, 14 can cause a mandible toadvance from a retruded position, neutral position, or advancedposition. The size and/or shape of the blocks 12, 14 can prevent,inhibit, or limit mandibular retrusion relative to a retruded position,neutral position, or advanced position of the mandible, whether such aposition is a natural position of a person, or whether it is caused bythe blocks 12, 14. In this way, the blocks 12, 14 can be configured tointeract with one another to treat TMD by repositioning the jaw and/orby adjusting the bite. The blocks 12, 14 can also be configured toreshape and/or maintain the airway and prevent, inhibit, or limit theairway from partially and/or entirely closing to treat SBD, for example,from a partially or entirely open configuration. Such an arrangement canadvantageously provide TMD and/or SBD treatment by repositioning the jawand/or by opening up the airway.

As described above, one or more maxillary blocks 12 can cooperate withone or more mandibular blocks 14 to reposition the jaw, adjust the bite,and/or reshape and/or maintain the airway. FIG. 3 illustrates that theblocks 12, 14 can cooperate with one another to move the mandibleforward. FIG. 3 also illustrates that the blocks 12, 14 can cooperatewith one another to reshape the airway into one or more openconfigurations, for example, by increasing the interocclusal separationbetween maxillary and mandibular dentitions. The blocks 12, 14 can bedesigned to maintain the mandible in one or more forward positions whenthe blocks 12, 14 are engaged with one another. The blocks 12, 14 canalso be designed to maintain the airway in one or more openconfigurations, including one or more reshaped configurations caused atleast partially by the interaction of the blocks 12, 14. The blocks 12,14 can interact with one another to reshape the airway by repositioning(also referred to as displacing) the mandible relative to the maxilla totreat TMD, or to additionally treat SBD, where the amount of mandibularadvancement and/or the interocclusal separation can be the same ordifferent when TMD and SBD are simultaneously being treated as comparedto when only TMD is being treated. For example, the TMD appliance 10 cancause less interocclusal separation (e.g., about 1 mm to about 40 mmless interocclusal separation, including every 1 mm increment withinthis range, for example, 10 mm) when treating only TMD as opposed toconcurrently treating TMD and SBD. As another example, the TMD appliance10 can cause less mandibular advancement (e.g., about 1 mm to about 20mm less mandibular advancement, including every 1 mm increment withinthis range, for example, 10 mm) when treating only TMD as opposed toconcurrently treating TMD and SBD. For example, the blocks 12, 14 can beconfigured to move the mandible forward and/or increase theinterocclusal separation between the maxillary and mandibular dentalarches when the blocks 12, 14 interact with one another. Suchdisplacement can advantageously reposition the jaw and adjust thebite—thus providing TMD treatment—can also advantageously reshape theairway and cause the airway to become more open—thus providing SBDtreatment.

The blocks 12, 14 can interact with one another to adjust the bite bymaintaining a neutral position (e.g., non-advanced position) or adisplaced position (e.g., advanced position) of the mandible relative tothe maxilla. The blocks 12, 14 can also interact with one another tomaintain an open airway by maintaining a neutral position (e.g.,non-advanced) or a displaced position (e.g., advanced position) of themandible relative to the maxilla. For example, the blocks 12, 14 canprevent, inhibit, or limit posterior movement of the mandible and/or areduction of the interocclusal distance when the mandible is in aneutral and/or displaced position. Such mandibular support canadvantageously treat TMD by training the jaw to return to a new, ormodified, neutral position. Such mandibular support can alsoadvantageously prevent, inhibit, or limit the tongue from falling backand collapsing the airway. A neutral position is considered any naturalocclusal position. A displaced position is considered any non-displacedposition, for example, any advanced and/or retruded position, natural orimposed. The blocks 12, 14 can cause a displaced mandibular position tobecome a new natural occlusal position, for example, by orthodonticallymanipulating (e.g., progressively manipulating with a series of traysand/or blocks) craniofacial structures over time such that the mandibleand associated structures acquire a new equilibrium (e.g., neutral)position.

The blocks 12, 14 can interact with one another to widen the maxillary(also referred to as superior or upper) dental arch and/or themandibular (also referred to as inferior or lower) dental arch. Forexample, the blocks 12, 14 can have one or more transverse slopes thatcan interact with one another to widen the hard and/or soft palates.Such widening can advantageously reshape the airway and cause it tobecome more open. Widening the mandibular dental arch can increase thesize of the sublingual space and decrease the amount of obstruction thetongue causes in the oral cavity. Widening the maxillary dental arch cancause palatal expansion and thereby increase the size of the oralcavity.

The blocks 12, 14 can interact to move the mandible forward, temporarilyor permanently. The blocks 12, 14 can also interact to cause the airwayto develop a more open configuration, temporarily or permanently. Theblocks 12, 14 can be configured to temporarily or permanently manipulatecraniofacial structures.

The one or more guide surface pairs 26-28 of the oral appliance 10(e.g., pair 26 a-28 a and/or pair 26 b-28 b) can interact in such amanner to prevent, inhibit, or limit posterior movement of the mandibleand associated structures (e.g., the tongue), for example, to treat TMDand/or SBD. The maxillary and mandibular guide surfaces 26, 28 can beconfigured to interact with one another or to otherwise contact eachother throughout treatment or only during a portion thereof. Asdescribed above, the blocks 12, 14 can be configured to interact in aself-guided manner.

FIG. 3 illustrates that a cooperating pair of guide surfaces 26 b, 28 bcan interact to advance the mandible into a forward position (alsoreferred to as advanced). FIG. 3 also illustrates that such advancementcan increase the interocclusal distance between the dental arches, butthe TMD appliance 10 can advance the mandible without increasing theinterocclusal distance as well. Where there is an increase in theinterocclusal distance, the resultant interocclusal distance can begreater than the natural interocclusal distance that would otherwiseresult between the arches if the jaw were simply advanced without theuse of guide surfaces 26, 28. For example, the resultant interocclusaldistance can be greater than the natural interocclusal separation thatthe alignment of the anterior teeth causes when the mandible is advancedwhen clenched. Where the anterior teeth do not produce naturaldisclusion upon the advancement of the mandible, the resultantinterocclusal distance that results can be due solely to one or morecooperating pairs of guide surfaces 26, 28 when the mandible isadvanced.

FIG. 3 illustrates that the closing of the jaws with a cooperating pairof guide surfaces 26, 28 can advance the mandible forward an advancementdistance 34. The advancement distance 34 can be from about 0 mm to about30 mm, more narrowly from about 0 mm to about 20 mm, yet more narrowlyfrom about 0 mm to about 10 mm, yet still more narrowly from about 5 mmto about 10 mm, including every 0.25 mm increment within these ranges,for example, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm,about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm.FIG. 3 illustrates that the cooperating pair of guide surfaces 26, 28can advance the mandible forward a sufficient advancement distance 34 toartificially create an underbite (also referred to as a Class IIImalocclusion). For example, the cooperating pair of guide surfaces 26,28 can advance the mandible forward such that the maxillary incisors arewithin the anterior perimeter (as opposed to posterior where the molarsare) of the mandibular incisors by, for example, from about 0.5 mm toabout 5.0 mm, including every 0.25 mm increment within this range.

The closing of the jaws with a cooperating pair of guide surfaces 26, 28can increase the interocclusal distance 36 between the dental archesfrom about 0 mm to about 60 mm, more narrowly from about 0 mm to about50 mm, more narrowly from about 0 mm to about 40 mm, yet more narrowlyfrom about 0 mm to about 30 mm, yet still more narrowly from about 0 mmto about 20 mm, yet more narrowly still from about 0 mm to about 10 mm,including every 0.25 mm increment within these ranges, for example,about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm.The range of natural disclusion can range from 0 mm to about 10 mm,including every 0.25 mm increment within this range. The interocclusaldistance 36 can be the height 12 _(H) of a maxillary block 12, theheight 14 _(H) of a mandibular block 14, or a combination thereof.

At least a portion of each pair of cooperating guide surfaces 26, 28(e.g., guide surfaces 26 b, 28 b) can contact each other when the jaw isbeing closed, for example from an open configuration to a closed (orless open) configuration. At least a portion of each pair of opposingguide surfaces 26, 28 can slidably contact each other such that at leasta portion of the guide surfaces 26, 28 slide past one another to advancethe mandible and increase the interocclusal distance when the jaw isclosed, for example, from an open configuration to a less openconfiguration. The cooperating guide surfaces can have a contact lengththat ranges from 0 mm when not in contact to about 1 mm to about 30 mmwhen in contact, including every 0.5 mm increment within this range. Thecontact length can increase from 0 mm to a maximum contact length as themandible is closed against the maxilla, or equivalently, as themandibular dentition is closed against the maxillary dentition. FIG. 3illustrates that the cooperating guide surfaces 26, 28 can have amaximum contact length of about 3 mm to about 15 mm, including every 0.5mm increment within this range, for example, 12 mm. The maximum contactlength can be the entire length or only part of the length of one orboth of the cooperating guide surfaces 26, 28. FIG. 3 illustrates thatthe maximum contact length can be the length of the maxillary guidesurfaces 26. Alternatively or additionally, at least a portion of eachpair of opposing guide surface 26, 28 can be configured to not slidablycontact each other, but rather merely rest against each another when thejaw is open to prevent, inhibit, or limit retrusion of the mandible.

For example, when the jaws are partially or fully closed, at least aportion of each pair of cooperating guide surfaces 26, 28 (e.g., guidesurfaces 26 b, 28 b) can contact its opposing guide surface such that atleast one of the guide surfaces 26, 28 prevents, inhibits, or limitsposterior movement of the mandible. For example, FIG. 3 illustrates thatthe maxillary second guide surface 26 b can interfere with (e.g.,prevent, inhibit, or limit) any posterior movement of the mandibularsecond guide surface 28 b, thereby interfering with any posteriormovement of the mandibular second block 14 b and the mandible.

The maxillary and mandibular blocks 12, 14 can cooperate to allow themandible to move in multiple directions when the jaws are in a fullyclosed position, for example, side-to-side, front-to-back, and/orup-and-down (or in any three mutually orthogonal reference planes). Forexample, the blocks 12, 14 can have a movement tolerance of about 1 mmto about 5 mm (e.g., including every 0.25 mm increment within thisrange) along three or fewer reference planes/axes to advantageouslymaximize comfort, reduce the likelihood of the TMD device 10 fromcausing new TMD issues, minimize sleep bruxism, and/or inhibit theblocks 12, 14 from becoming dislodged while concurrently treating TMD,SBD, and/or snoring. The posterior guide surface of a posterior-anteriorguide surface pair can, for example, resist but allow posterior movementof the anterior guide surface. The posterior and anterior guide surfacescan be any two opposing surfaces, for example, the maxillary secondguide surface 26 b and the mandibular second guide surface 28 b pair,with the maxillary second guide surface 26 b being posterior to themandibular second guide surface 28 b. Alternatively or additionally, theposterior guide surface can freely allow posterior movement of theanterior guide surface over the tolerance range and then begin to resistfurther posterior movement. For example, the posterior and anteriorguide surfaces (e.g., posterior guide surfaces 26 and anterior guidesurfaces 28) can be partially or entirely coated with the coatingdescribed above. The maxillary and mandibular guide surface angles 30,32 can have angles that self-guide the mandible to return to a moreforward position when the mandible moves posteriorly. The maxillary andmandibular blocks 12, 14 can cooperate to allow the mandible to have sixdegrees of freedom when the jaw is being opened and closed. Themaxillary and mandibular blocks 12, 14 can be locked together when themandible is in an advanced position, and allow movement within thetolerance range within one, two, three, four, five, and/or six degreesof freedom. The maxillary and mandibular blocks 12, 14 can be attachedto one another (e.g., a maxillary block 12 can be attached to amandibular block 14), for example, via an interference fit (alsoreferred to as a friction fit), snap fit, a tether, band, elastic band,hook, elastic hook, or any combination thereof, with or without one,two, three, four, five, and/or six degrees of freedom. For example, themaxillary blocks 12 can have a protrusion and the mandibular blocks 14can have a recess configured to receive the protrusion via aninterference fit or a snap fit.

Alternatively or additionally, the TMD appliances 10 disclosed hereincan allow free mandibular motion except for the retrusion prevented,inhibited, or limited by two opposed guide surface pairs 26, 28 whenthey are in a position to interact with one another.

As described above, a series of blocks 12, 14 can be designed andapplied or used over time to move one or more teeth, advance and/ormaintain a position of the mandible, increase the interocclusal distance36 and/or widen the hard and/or soft palates in two or more successivesteps in a series. Exemplary dimensional variations are disclosed below,but these are in no way limiting, as every permutation of the dimensionsand relative positions herein disclosed is appreciated, for example,including every 0.25 mm increment or 0.5% increment within thedimensional ranges disclosed herein. Successive dimensional changes canadvantageously achieve the desired treatment in each step in a series.Each block 12, 14 in a series can have guide surface angles 30, 32 thatcorrespond to an intermediate or end mandible advancement position orinterocclusal distance intended for the block 12, 14 in the series. Eachblock 12, 14 in a series can have block lengths, widths and heights 12_(L), 14 _(L), 12 _(w), 14 _(w), 12 _(H), 14 _(H) that correspond to anintermediate or end mandible advancement position or interocclusaldistance intended for the block 12, 14 in the series. Each block 12, 14in a series can have guide surface lengths 26 _(L), 28 _(L) thatcorrespond to an intermediate or end mandible advancement position orinterocclusal distance intended for the block 12, 14 in the series.

Each block 12, 14 in a series can be configured to contact a differentportion or a length of a guide surface of an opposing block. Each block12, 14 in a series can have a longitudinal and/or transverse slope thatcorresponds to an intermediate or end mandible advancement position orinterocclusal distance intended for the block 12, 14 in the series. Oneor more of the dimensions disclosed can be increased, decreased, orremain unchanged from one treatment step to the next treatment step(i.e., one or more dimensions can remain unchanged between two treatmentsteps). For example, one or more dimensions can be increased and/ordecreased from a first dimension to a second dimension between twotreatment steps (e.g., between a first treatment step and a secondtreatment step with no treatment step between the first and secondtreatment steps, or between any two treatment steps) such that thesecond dimension is about 0.5 mm to about 40 mm greater than or lessthan the value of the first dimension in the first treatment step thanin the second (e.g., subsequent) treatment step, for example, every 0.25mm increment between 0.5 mm and 40 mm (e.g., 0.5 mm, 1.0 mm, 1.5 mm, 2.0mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm and so on). Forexample, one or more dimensions can be increased and/or decreased from afirst dimension to a second dimension between two treatment steps (e.g.,between a first treatment step and a second treatment step with notreatment step between the first and second treatment steps, or betweenany two treatment steps) such that the second dimension is about 1% toabout 500% greater than or less than the value of the first dimension inthe first treatment step than in the second (e.g., subsequent) treatmentstep, for example, every 1% increment between 1% and 500% (e.g., 1%, 5%,10%, 15%, 20%, 25%, 30%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%,85%, 90%, 95%, 100%, 125%, 150%, 175% and so on).

In a treatment series, the blocks 12, 14 can move one or more teeth,reposition the mandible, adjust the bite, adjust the interocclusaldistance, and/or widen the hard and/or soft palates to an intermediateor end arrangement as desired in one or more treatment steps in aseries. The blocks 12, 14 can progressively move teeth, increase and/ordecrease the advancement distance 34, increase and/or decrease theinterocclusal distance 36, widen the hard and/or soft palates, adjustthe bite, or any combination thereof. For example, the blocks 12, 14 ina series can progressively increase the advancement distance 34 from afirst distance to a second distance greater than the second distance.The blocks 12, 14 in a series can progressively decrease the advancementdistance 34 from the second distance to a third distance less than thesecond distance and greater than the first distance. As another example,the blocks 12, 14 in a series can progressively increase theinterocclusal distance 36 from a first distance to a second distancegreater than the first distance. The blocks 12, 14 in a series canprogressively decrease the interocclusal distance 36 from the seconddistance to a third distance less than the second distance and greaterthan the first distance. As another example, the blocks 12, 14 in aseries can progressively increase the width of a palate from a firstwidth to a second width greater than the first width. The design of aseries of blocks can advantageously reduce the initial shock oftreatment to the affected craniofacial (e.g., mandible, dental arches,airway, palate) structures potentially caused by the blocks 12, 14 andtherefore make the treatment more comfortable. Exemplary dimensionalvariations are disclosed below, but these are in no way limiting, asevery permutation of the dimensions and relative positions hereindisclosed is appreciated, for example, including every 0.25 mm incrementor 0.5% increment within the dimensional ranges disclosed herein. One ormore of the dimensions disclosed can be increased, decreased, or remainunchanged from one treatment step to the next treatment step (i.e., oneor more dimensions can remain unchanged between two treatment steps).Such craniofacial dimensions (e.g., dimensions 34 and 36) can beincreased and/or decreased from a first dimension to a second dimensionbetween two treatment steps (e.g., between a first treatment step and asecond treatment step with no treatment step between the first andsecond treatment steps, or between any two treatment steps) such thatthe second dimension is about 0.5 mm to about 40 mm greater than or lessthan the value of the first dimension in the first treatment step thanin the second (e.g., subsequent) treatment step, for example, every 0.5mm increment between 0.5 mm and 40 mm (e.g., 0.5 mm, 1.0 mm, 1.5 mm, 2.0mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm and so on). Suchcraniofacial dimensions (e.g., dimensions 34 and 36) can be increasedand/or decreased from a first dimension to a second dimension betweentwo treatment steps (e.g., between a first treatment step and a secondtreatment step with no treatment step between the first and secondtreatment steps, or between any two treatment steps) such that thesecond dimension is about 1% to about 500% greater than or less than thevalue of the first dimension in the first treatment step than in thesecond (e.g., subsequent) treatment step, for example, every 1%increment between 1% and 500% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%,40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 100%, 125%,150%, 175% and so on).

FIG. 5 illustrates a variation of an aligner 38 on teeth. The aligner 38can have the properties of the oral trays described herein. For example,the aligner 38 can be a maxillary dentition aligner 38 a or a mandibulardentition aligner 38 b. The aligner 38 can have an inner surface and anouter surface. The inner surface can define a tooth-receiving cavity.The inner surface can be configured to contact one or more teeth. Theinner surface can have a geometry configured to move one or moremaxillary or mandibular teeth from a first position to a secondposition, for example, by exerting a force on one or more teeth (e.g.,from an interference fit configured to move one or more teeth). Thealigner 38 can fit over all or a subset of teeth in the maxillary and/ormandibular dentition.

A series of aligners 38 (e.g., maxillary and/or mandibular aligners 38a, 38 b) can be designed and applied or used over time in order toreposition one or more maxillary and/or mandibular teeth in two or moresuccessive steps, for example, as disclosed in PCT Publication WO2016/004415 and U.S. application Ser. No. 15/386,280 (published as US2017/0100214), both of which have been incorporated herein by referencein their entireties for all purposes. As described above, each aligner38 in a series can have an inner surface that has a geometry thatcorresponds to an intermediate or end tooth arrangement intended foreach aligner 38 in the series. The aligners 38 can be sufficientlyresilient to accommodate or conform to misaligned teeth, but applysufficient force against the misaligned teeth to reposition the teeth tothe intermediate or end arrangement as desired for the particulartreatment step. A series of aligners 38 can have geometries selected toprogressively reposition teeth from a first arrangement through one ormore successive intermediate arrangements to a final arrangement.

TMD appliance therapy can be combined with orthodontic aligner treatmentas described above, for example, with an aligner 38 (e.g., a maxillaryand/or mandibular aligner 38 a, 38 b). As further described above, oneor more craniofacial adjustment blocks 12 and/or 14 (also referred to asguides and TMD components) can be directly or indirectly attached to orintegrated with an aligner 38 (e.g., a maxillary and/or mandibularaligner 38 a, 38 b). The one or more maxillary blocks 12 can bemonolithically formed with a maxillary aligner 38 a. The one or moremandibular blocks 14 can be monolithically formed with a mandibularaligner 38 a.

FIG. 6 illustrates that a maxillary aligner 38 a can have a maxillaryguide 12 that has a guide surface 26. The guide 12 can be on an anterioror posterior portion of the maxillary aligner 38 a. For example, FIG. 6illustrates that the guide 12 can be on an anterior portion of thealigner 38 a. The guide 12 can be one of the block 12, 14 describedabove with reference to FIGS. 1-3, and can be integrated with thealigner 38 a as shown in FIG. 6.

FIG. 7 illustrates that the guide 12 can be on a posterior portion ofthe aligner 38 a. The aligner 38 a can advantageously orthodonticallymove teeth concurrently with treating TMD and/or SBD, for example, byinteracting with a mandibular aligner 38 b. For example, FIG. 7illustrates a jaw in a closed position having a maxillary aligner 38 aand a mandibular aligner 38 b with posterior guides 12, 14, where theposterior guides 12, 14 are interacting to keep the jaw in a closedposition with more space between the upper and lower dentition thanwould otherwise occur without the posterior guides 12, 14. The guides12, 14 can be the blocks 12, 14 described above with reference to FIGS.1-3, and can be integrated with the aligners 38 a,38 b, respectively, asshown in FIG. 7.

FIGS. 1-3, 6 and 7 each illustrate TMD components comprising angledsurfaces and disclusion ramps such as craniofacial adjustment blocks 12,14 that can be combined with the aligner 38 in FIG. 5 to concurrentlyprovide TMD treatment along with the orthodontic movement of teeth.However, all types of TMD appliance therapy can be combined withorthodontic aligner treatment shown in FIG. 5, including othermandibular advancement appliances (e.g., Herbst appliances, elasticmandibular advancement (EMA) appliances), as well as, for example,stabilization splints (e.g., nightguards, day guards), deprogrammers(e.g., anterior deprogrammers), flat planes, and full contact splintswith anterior guidance. For example, the aligner 38 can be combinedwith, attached to, removably attached to, or integrated with these othertypes of TMD components. The aligner 38 can replace the teeth (e.g.,occlusal) engagement portions of these other types of TMD components sothat each appliance 10 can orthodontically move teeth in addition toproviding TMD treatment. Such orthodontic/TMD appliances canadvantageously orthodontically move the teeth into a position that isphysiologically correct for the TMJ and musculature during TMD treatmentwith a TMD appliance. The maxillary and mandibular aligner componentsand/or the TMD components of these oral appliances 10 can comprise athermoplastic material that can, for example, be thermoformed with theaid of a computer program.

The aligners described herein can form a friction fit with thedentition. The friction fit can be non-uniformly spread across thealigners to apply different forces to different teeth, thereby enablingdifferent teeth to be orthodontically moved by different amounts, withthe amounts being proportionate to the various (e.g., different) forcesapplied across the dentition.

Two sets of oral appliances 10 can be made for every stage of treatment:one for daytime use and one for nighttime use. The daytime oralappliances 10 can orthodontically move teeth. The daytime oralappliances can provide TMD treatment. For example, the daytime oralappliances 10 can have a TMD component that is smaller than thenighttime oral appliances 10, or the daytime oral appliances 10 can omitthe TMD component altogether. The nighttime oral appliances 10 canconcurrently treat TMD and orthodontically move teeth. The nighttimeoral appliances can have a TMD component. . Each daytime oral appliance10 in a series can be designed to open and/or advance the lower jaw lessthan the corresponding nighttime oral appliance 10 in the series, or notat all. The daytime and nighttime appliances can have the samecorresponding stage of orthodontic treatment. The daytime stage oforthodontic treatment can be less aggressive (e.g., apply less force tothe teeth) than the nighttime stage of orthodontic treatment.Alternatively or additionally, only one series of oral appliances 10 canbe made for every step of treatment (as opposed to two parallel seriesof appliances—one for day use and one for night use). For example, oneor more of the locked configurations of the appliance 10 in each step ofa series can be for daytime use and one or more of the lockedconfigurations of the appliance 10 in each step of a series can be fornighttime use.

FIG. 8 illustrates a schematic of a variation of a series 200 of oralappliances 10. The oral appliance series 200 can have N_(D) daywear oralappliances 10 in a daytime series 200 _(D) and/or can have N_(N)nightwear oral appliances 10 in a nighttime series 200 _(N), where N_(D)and N_(N) can each be between 1 and 100, including every increment of 1within this range. N_(D) can be the same or different from N_(N). Thedimensions of the daytime and nighttime oral appliances 10 in each stepof the series 200 can be the same or different than one another. Thedaytime and nighttime oral appliances 10 in each step of the series 200can advance the jaw as described above, for example, by the same amount.For example, FIG. 8 illustrates that steps 1-4 of the series 200 caneach progressively move the jaw forward by about 1.0 mm, by about 0.5mm, by about 0.5 mm, and by about 1.0 mm, respectively, which isrepresented in FIG. 8 by arrows 201, 202, 203, and 204, respectively.FIG. 8 illustrates the relative positions of the maxillary aligner andTMD components (e.g., aligner 38 a and TMD components 12) relative tothe mandibular aligner and TMD components (e.g., aligner 38 b and TMDcomponents 14).

Method of Making

FIG. 9 illustrates a variation of a process 100 of making the oralappliance 10. A computer program can be used to retrieve data from dataacquisition devices (e.g., oral scanners, x-ray devices, cameras) torecord and measure orthodontic malocclusions and teeth misalignments.Step 102 illustrates that after a digital model of the dentition isobtained, the digital models for the lower and upper arches can beloaded, e.g., into a computer. Step 104 illustrates that the biteregistration can be set and a temporomandibular joint (TMJ) model can becreated. The desired treatment can be simulated in step 106, including,for example, mandibular advancement, palatal expansion, teeth movement,or any combination thereof. The TMJ temporal bone, disc and mandibularhead relationship can be checked in step 108, for example, whenmandibular advancement is simulated in step 106. If the check issatisfactory, the process can move on to step 110, otherwise the processcan return to step 106 and run one or more additional simulations. Basedat least partly on the simulation(s) and check(s) in steps 106 and 108,an algorithm can be configured to design one or more aspects of the TMDcomponents (e.g., guide surfaces 26, 28) in step 110 to effect thedesired mandibular advancement. Step 112 illustrates that the blocks 12,14 and/or oral trays can be designed that have the guide surfaces 26, 28designed in step 110. Step 112 also illustrates that an optional elastichook can be designed to prevent the jaw from opening and moving awayfrom the maxillary blocks 12 when a person is sleeping. Step 114illustrates that the blocks 12, 14 and/or oral trays designed in step112 can move one or more teeth to a new arch occlusion based on a newarch relationship at least partly determined by the algorithm. Theprocess 100 can be used to create one oral appliance 10 or a series oforal appliances 10.

Software can be used to manipulate digital impressions (scans) of thedental arches to incrementally move the teeth as well as designing thefunctional applications for daytime and/or nighttime use on a 3D printedmodel for appliance fabrication utilizing traditional vacu-formtechnique or direct to print appliances.

Using the process 100 in FIG. 9, an oral appliance 10 and/or a series oforal appliances 10 can be designed by the computer algorithm based ondata the algorithm receives and processes from one or multiple dataacquisition devices (e.g., scanners, x-ray devices, cameras) that canindividually or collectively form a digital impression of an oral cavityand the dentition therein. For example, the dimensions of the oralappliance 10 in each step, including the TMD components (e.g., maxillaryand mandibular blocks 12, 14, or one or more aspects thereof, includingthe oral trays) and/or the aligner components (e.g., maxillary andmandibular aligners 38 a, 38 b) can be determined from data receivedfrom the data acquisition devices. The algorithm in process 100 cancombine orthodontic aligners with multiple different discipline TMDtreatments, for example, to adjust the bite, restore some or all of theteeth, and move the teeth into a more desirable position.

For example, the data retrieved from the data acquisition devices can beused to measure orthodontic malocclusions, determine orthodonticcorrections for the malocclusions while simultaneously treating TMD, forexample, by designing a series of oral appliances 10 that canprogressively treat TMD concurrently with a progressive orthodonticmovement of teeth. Computer software can be used to determine theorthodontic movements of the teeth in one or more steps of a series.Computer software can be used to design the appliances 10. Computersoftware can be used to manufacture 3D models or directly printappliances 10. Models of the appliances 10 can be created by usingcomputer software to incrementally move the teeth digitally and thenprint a 3D model from which an orthodontic aligner can be fabricated.Alternatively or additionally, the aligners can be fabricated directlywith a 3D printer using computer software. The orthodontic aligner canbe altered or otherwise modified on the occlusal surface to create thedesired TMD treatment appliance 10 while the orthodontic movement isconcurrently occurring. Giving the dentist or orthodontist the abilityto treat TMD simultaneously with the orthodontic movement of teeth via acomputer program that converts data received from one or more dataacquisition devices into a series of successive orthodontic/TMDappliances 10 can advantageously open up many new treatment protocolsfor dentists and orthodontists to use to serve their patients. Suchorthodontic/TMD appliances 10 can limit or reduce the need for surgeryand restorative dental work (often times extensive or significant) thatis typically occurs when TMD is treated with TMD appliances without theconcurrent orthodontic movement of teeth. The orthodontic/TMD appliances10 disclosed herein avoid such drawbacks of solo TMD appliances byorthodontically moving the teeth into a position which isphysiologically correct for the TMJ and musculature.

The claims are not limited to the exemplary embodiments shown in thedrawings, but instead may claim any feature disclosed or contemplated inthe disclosure as a whole. Any elements described herein as singular canbe pluralized (i.e., anything described as “one” can be more than one).Any species element of a genus element can have the characteristics orelements of any other species element of that genus. Some elements maybe absent from individual figures for reasons of illustrative clarity.The above-described configurations, elements or complete assemblies andmethods and their elements for carrying out the disclosure, andvariations of aspects of the disclosure can be combined and modifiedwith each other in any combination. All devices, apparatuses, systems,and methods described herein can be used for medical (e.g., diagnostic,therapeutic or rehabilitative) or non-medical purposes.

What is claimed is:
 1. An oral appliance for the combined orthodonticmovement of teeth and treatment of temporomandibular joint dysfunction(TMD), comprising: a first orthodontic aligner; a second orthodonticaligner; and a TMD treatment device, comprising: a first guide having afirst angled guide surface positioned along the first orthodonticaligner; and a second guide having a second angled guide surfacepositioned along the second orthodontic aligner, the second angled guidesurface having a second angled guide surface length, wherein when thefirst orthodontic aligner is worn by a user, the first angled guidesurface is between a buccal side and a lingual side of a first maxillarytooth, wherein when the second orthodontic aligner is worn by the user,the second angled guide surface is between a buccal side and a lingualside of a first mandibular tooth, wherein when the first and secondorthodontic aligners are worn by the user and the user's lower jaw is ina fully closed position such that the first and second angled guidesurfaces are in contact with one another and such that the second guideis pressed against a portion of the first orthodontic aligner thatextends between a buccal side and a lingual side of a second maxillarytooth, the first and second guides are in a fully engaged configuration,wherein when the first and second guides are in the fully engagedconfiguration, the first guide is opposed to the second guide, whereinwhen the first and second guides are in the fully engaged configuration,the first guide has a free surface positioned to not contact the secondguide such that a gap is defined between the free surface and the secondguide, the free surface having a free surface length, the free surfacelength being less than the second angled guide surface length, whereinwhen the first and second guides are in the fully engaged configuration,the free surface is between a buccal side and a lingual side of a secondmandibular tooth, wherein when the first and second guides are in thefully engaged configuration, the free surface faces the second guidesurface, and wherein the oral appliance is configured to concurrentlyreposition a mandible and orthodontically move one or more teeth, andwherein the second guide surface is at a constant angle relative to thefree surface.
 2. The oral appliance of claim 1, wherein the TMDtreatment device comprises at least one of a mandibular advancementappliance, a stabilization splint and a deprogrammer.
 3. The oralappliance of claim 1, wherein the oral appliance further comprises oneor more locking mechanisms configured to restrict movement of themandible when the one or more locking mechanisms are engaged with oneanother.
 4. The oral appliance of claim 3, wherein the mandible isallowed to move in one, two, three, four, five, or six degrees offreedom when the one or more locking mechanisms are engaged with oneanother.
 5. The oral appliance of claim 3, wherein the mandible isallowed to translate along one, two, or three axes when the one or morelocking mechanisms are engaged with one another.
 6. The oral applianceof claim 5, wherein the mandible is allowed to translate from 0.5 mm to10.0 mm along one or more of the one, two, or three axes when the one ormore locking mechanisms are engaged with one another.
 7. The oralappliance of claim 3, wherein the one or more locking mechanismscomprise at least one of clasps, clips, hooks, elastic hooks, barbs,spurs, fasteners, elastic bands, interlocking male and femalecomponents.
 8. A system for the combined orthodontic movement of teethand treatment of temporomandibular joint dysfunction (TMD), comprising:a series of oral appliances configured to concurrently reposition both amandible and orthodontically move one or more teeth, wherein each oralappliance in the series comprises: a first orthodontic tray and a secondorthodontic tray, wherein the first and second orthodontic trayscomprise a TMD treatment device, the TMD treatment device comprising: afirst guide that extends from the first orthodontic tray, wherein thefirst guide has a first angled guide surface, a first guide base, and afree surface, and wherein the free surface is opposite the base; and asecond guide that extends from the second orthodontic tray, wherein thesecond guide has a second angled guide surface, a second guide base, anda surface angled relative to the second angled guide surface, andwherein the second guide base is opposite the surface angled relative tothe second angled guide surface, wherein when the first and secondguides are in contact with one another and the first guide base and thesurface angled relative to the second angled guide surface are in thesame plane, the first guide is opposed to the second guide and the firstangled guide surface is in contact with a first portion of the secondangled guide surface, wherein when the first and second guides are incontact with one another and the first guide base and the surface angledrelative to the second angled guide surface are in the same plane, thefree surface does not contact the second guide such that a gap isdefined between the free surface and the second guide, wherein when thefirst and second guides are in contact with one another and the firstguide base and the surface angled relative to the second angled guidesurface are in the same plane, the free surface faces a second portionof the second angled guide surface, and wherein the first and secondportions of the second angled guide surface are at the same anglerelative to the free surface, and wherein the first and second guidesare located between buccal and lingual sides of maxillary and mandibularteeth, respectively.
 9. The system of claim 8, wherein the seriescomprises 2 to 100 oral appliances.
 10. The system of claim 8, whereineach oral appliance in the series is configured to progressivelyreposition one or more maxillary teeth and/or one or more mandibularteeth.
 11. The system of claim 8, wherein one or more oral appliances inthe series is configured to progressively advance the mandible by 0.25mm or by 0.5 mm.
 12. The system of claim 8, wherein each oral appliancein the series is configured to progressively advance the mandible by0.25 mm or by 0.5 mm.
 13. The system of claim 8, wherein the TMDtreatment device comprises at least one of a mandibular advancementappliance, a stabilization splint and a deprogrammer.
 14. The system ofclaim 8, wherein one or more of the TMD treatment devices in the seriescomprises one or more locking mechanisms configured to restrict movementof the mandible when the one or more locking mechanisms are engaged withone another.
 15. The system of claim 14, wherein the mandible is allowedto translate along one, two, or three axes when the one or more lockingmechanisms are engaged with one another.
 16. The system of claim 15,wherein the mandible is allowed to translate from 0.5 mm to 10.0 mmalong one or more of the one, two, or three axes when the one or morelocking mechanisms are engaged with one another.
 17. The system of claim8, wherein the series of oral appliances comprises a first oralappliance having first oral appliance dimensions and a second oralappliance having second oral appliance dimensions, wherein one or moreof the second oral appliance dimensions are greater than or less thanone or more of the first oral appliance dimensions.
 18. The system ofclaim 17, wherein one or more of the second oral appliance dimensionsare greater than or less than one or more of the first oral appliancedimensions by 1% to 500% or by 0.5 mm to 10.0 mm.
 19. A method ofprogressively treating temporomandibular joint dysfunction (TMD),comprising: providing a series of oral appliances configured toconcurrently reposition both a mandible and orthodontically move one ormore teeth, wherein each oral appliance in the series comprises: a firstorthodontic tray; a second orthodontic tray; and a TMD treatment device,comprising: a first guide having a first angled guide surface positionedalong the first orthodontic tray, the first guide extending from thefirst orthodontic tray; and a second guide having a second angled guidesurface positioned along the second orthodontic tray, the second guideextending from the second orthodontic tray, wherein when the firstorthodontic tray is worn by a user, the first angled guide surface isbetween a buccal side and a lingual side of a first maxillary tooth,wherein when the second orthodontic tray is worn by the user, the secondangled guide surface is between a buccal side and a lingual side of afirst mandibular tooth, wherein when the first and second orthodontictrays are worn by the user and the user's lower jaw is in a fully closedposition such that the first and second angled guide surfaces are incontact with one another and such that the second guide is pressedagainst a portion of the first orthodontic tray that extends between abuccal side and a lingual side of a second maxillary tooth, the firstand second guides are in a fully engaged configuration, wherein when thefirst and second guides are in the fully engaged configuration, thefirst guide is opposed to the second guide, wherein when the first andsecond guides are in the fully engaged configuration, the first guidehas a free surface positioned to not contact the second guide such thata gap is defined between the free surface and the second guide, whereinwhen the first and second guides are in the fully engaged configuration,the free surface is opposite the second angled guide surface, andwherein when the first and second guides are in the fully engagedconfiguration, the free surface is between a buccal side and a lingualside of a second mandibular tooth and wherein the second angled guidesurface is at a constant angle relative to the free surface.
 20. Themethod of claim 19, wherein the series comprises 2 to 100 oralappliances, and wherein the TMD treatment device comprises at least oneof a mandibular advancement appliance, a stabilization splint and adeprogrammer.
 21. The oral appliance of claim 1, wherein the first guidehas a first guide height, wherein the free surface defines an apex ofthe first guide height, wherein the free surface has a free surfaceproximal terminal end and a free surface distal terminal end, whereinwhen the first and second guides are in the fully engaged configuration,the free surface proximal terminal end is closer to a front of theuser's mouth than the free surface distal terminal end, wherein thesecond guide angled surface has a second guide angled surface proximalterminal end and second guide angled surface distal terminal end,wherein when the first and second guides are in the fully engagedconfiguration, the second guide angled surface proximal terminal end iscloser to a front of the user's mouth than the second guide angledsurface distal terminal end, wherein when the first and second guidesare in the fully engaged configuration first, the second guide angledsurface proximal terminal end is closer to maxillary teeth than thesecond guide angled surface distal terminal end, wherein when the firstand second guides are in the fully engaged configuration, the secondguide angled surface distal terminal end is closer to mandibular teeththan the second guide angled surface proximal terminal end, wherein whenthe first and second guides are in the fully engaged configuration, thefree surface distal terminal end is distal of the second guide angledsurface distal terminal end such that the free surface distal terminalend is further from the front of the user's mouth than the second guideangled surface distal terminal end, and wherein when the first andsecond guides are in the fully engaged configuration, the free surfaceproximal terminal end and the free surface distal terminal end are bothdistal to the second angled guide surface proximal terminal end.
 22. Theoral appliance of claim 21, wherein the second guide has a second guideheight, and wherein the first guide height is less than the second guideheight.
 23. The oral appliance of claim 21, wherein the second guide hasa second guide height, wherein when the first and second guides are inthe fully engaged configuration, the second guide height is measuredbetween a mandibular tooth surface and an apex of the second guide,wherein when the first and second guides are in the fully engagedconfiguration, the apex of the first guide height is between themandibular tooth surface and a maxillary tooth surface, and wherein whenthe first and second guides are in the fully engaged configuration, theapex of the first guide height is between the mandibular tooth surfaceand the apex of the second guide.
 24. The system of claim 8, wherein thefirst guide has a first guide height, and wherein the free surfacedefines an apex of the first guide height.
 25. The system of claim 8,wherein the first angled guide surface has a first angled guide surfacelength, wherein the second angled guide surface has a second angledguide surface length, and wherein the first angled guide surface lengthis less than the second angled guide surface length.
 26. The system ofclaim 8, wherein when the first and second guides are in contact withone another, the second angled guide surface extends away from the freesurface.
 27. The system of claim 8, wherein the free surface has a freesurface first end and a free surface second end, and wherein when thefirst and second guides are in contact with one another, the freesurface first end is closer to the second angled guide surface than thefree surface second end.
 28. The oral appliance of claim 1, wherein whenthe first and second guides are in the fully engaged configuration, thefirst angled guide surface is in contact with a first portion of thesecond angled guide surface and the free surface faces a second portionof the second angled guide surface, and wherein the first and secondportions of the second angled guide surface are at the same anglerelative to the free surface.
 29. The oral appliance of claim 1, whereinwhen the first and second guides are in the fully engaged configuration,the first angled guide surface is in contact with a first portion of thesecond angled guide surface and the free surface faces a second portionof the second angled guide surface, and wherein the first and secondportions of the second angled guide surface are at the same anglerelative to each other.
 30. The oral appliance of claim 1, wherein whenthe first and second guides are in the fully engaged configuration, thefirst angled guide surface is in contact with a first portion of thesecond angled guide surface and the free surface faces a second portionof the second angled guide surface, and wherein the first and secondportions of the second angled guide surface are at the same anglerelative to a surface of the first maxillary tooth, to a surface of thesecond maxillary tooth, to a surface of the first mandibular tooth, orto a surface of the second mandibular tooth.
 31. The system of claim 8,wherein when the first and second orthodontic trays are worn by a userand the user's lower jaw is in a fully closed position such that thefirst and second angled guide surfaces are in contact with one anotherand such that the second guide is pressed against a portion of the firstorthodontic tray that extends between a buccal side and a lingual sideof a maxillary tooth, the first and second guides are in a fully engagedconfiguration, wherein when the first and second guides are in the fullyengaged configuration, the second angled guide surface extends away fromthe free surface, wherein the free surface has a free surface first endand a free surface second end, and wherein when the first and secondguides are in the fully engaged configuration, the free surface firstend is closer to the second angled guide surface than the free surfacesecond end.
 32. The system of claim 31, wherein when the first andsecond guides are in the fully engaged configuration, the first portionof the second angled guide surface extends away from the free surface ina first direction and the second portion of the second angled guidesurface extends away from the free surface in a second directionopposite the first direction.